Trial Outcomes & Findings for Real World Expanded Multicenter Study of the MitraClip® System (REALISM) (NCT NCT01931956)

NCT ID: NCT01931956

Last Updated: 2018-12-04

Results Overview

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 965 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-12-04

Participant Flow

As of February 13, 2018, a total of 59 Compassionate Use and 7 Emergency Use patients have undergone MitraClip procedure between 14 Dec 2010 and 22 Feb 2013. A total of 628 patients in the High Risk arm between January 22, 2009 and December 19, 2013 and 271 patients in the Non-High Risk arm were enrolled between January 22, 2009 and April 14, 2011.

Patients who did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either EU or CU.

Participant milestones

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high Risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant
Overall Study STARTED	59	7	628	271
Overall Study COMPLETED	8	0	141	138
Overall Study NOT COMPLETED	51	7	487	133

Reasons for withdrawal

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high Risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant
Overall Study Death	42	7	379	96
Overall Study Withdrawal by Subject	5	0	70	30
Overall Study Lost to Follow-up	2	0	11	7
Overall Study Expected	2	0	6	0
Overall Study Not due	0	0	21	0

Baseline Characteristics

Real World Expanded Multicenter Study of the MitraClip® System (REALISM)

Baseline characteristics by cohort

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high Risk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Total n=965 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	1 Participants n=7 Participants	75 Participants n=5 Participants	41 Participants n=4 Participants	125 Participants n=21 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants	6 Participants n=7 Participants	553 Participants n=5 Participants	230 Participants n=4 Participants	840 Participants n=21 Participants
Age, Continuous	75.2 years STANDARD_DEVIATION 9.2 • n=5 Participants	78.6 years STANDARD_DEVIATION 11.1 • n=7 Participants	76.7 years STANDARD_DEVIATION 10.7 • n=5 Participants	73.9 years STANDARD_DEVIATION 11.2 • n=4 Participants	75.5 years STANDARD_DEVIATION 9.4 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	3 Participants n=7 Participants	253 Participants n=5 Participants	127 Participants n=4 Participants	400 Participants n=21 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	4 Participants n=7 Participants	375 Participants n=5 Participants	144 Participants n=4 Participants	565 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	34 Participants n=5 Participants	9 Participants n=4 Participants	46 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	7 Participants n=7 Participants	594 Participants n=5 Participants	262 Participants n=4 Participants	919 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	47 Participants n=5 Participants	12 Participants n=4 Participants	63 Participants n=21 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	6 Participants n=7 Participants	563 Participants n=5 Participants	246 Participants n=4 Participants	869 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment United States	59 participants n=5 Participants	7 participants n=7 Participants	628 participants n=5 Participants	271 participants n=4 Participants	66 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Intent-To-Treat Population set (ITT)

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events	5 Participants	3 Participants	98 Participants	31 Participants

PRIMARY outcome

Timeframe: 12 months

Population: ITT population

A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events	31 Participants	5 Participants	223 Participants	74 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis was performed in 52 participants out of 59 in CU arm, in 6 subjects out of 7 in EU arm, in 556 participants out of 628 participants and 248 out of 271 participants in non-HR arm were analyzed.

Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).

Outcome measures

Measure	Compassionate Use n=52 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=556 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=248 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With 12-Month Efficacy	25 Participants	1 Participants	339 Participants	166 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population

The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Serious Adverse Events	11 participants	5 participants	204 participants	68 participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Serious Adverse Events	37 Participants	7 Participants	388 Participants	131 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population

Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)	2 Participants	0 Participants	14 Participants	11 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)	3 Participants	0 Participants	22 Participants	15 Participants

SECONDARY outcome

Timeframe: 30 days

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=26 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age	3 Participants	2 Participants	64 Participants	16 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=26 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age	14 Participants	3 Participants	139 Participants	40 Participants

SECONDARY outcome

Timeframe: 2 years

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=26 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age	14 Participants	4 Participants	146 Participants	40 Participants

SECONDARY outcome

Timeframe: 3 years

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=26 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age	14 Participants	4 Participants	146 Participants	40 Participants

SECONDARY outcome

Timeframe: 4 years

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 24 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=24 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age	12 Participants	4 Participants	146 Participants	40 Participants

SECONDARY outcome

Timeframe: 5 years

Population: CU Arm: There are 27 patients \>75 years old in the CU arm. Safety data are available only for 24 patients. EU Arm: There are 5 patients \>75 years old in the EU arm. HR arm: There are 393 patients \>75 years old in the HR arm. Non-HR arm: There are 140 patients \>75 years old in the Non-HR arm.

MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.

Outcome measures

Measure	Compassionate Use n=24 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=393 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=140 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age	12 Participants	4 Participants	146 Participants	40 Participants

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure)

Population: ITT population

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Acute Procedural Success	41 Participants	3 Participants	524 Participants	229 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population

Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Procedural Success	45 Participants	4 Participants	541 Participants	239 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Clinical Durability	22 Participants	0 Participants	325 Participants	163 Participants

SECONDARY outcome

Timeframe: On the day of index procedure (≤1 day)

Population: ITT population

Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Clip Implant Rate	55 Participants	7 Participants	603 Participants	258 Participants

SECONDARY outcome

Timeframe: On the day of index procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.

Outcome measures

Measure	Compassionate Use n=58 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=619 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=262 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Procedure Time	141.7 minutes Standard Deviation 70.4	123.6 minutes Standard Deviation 55.9	139.0 minutes Standard Deviation 66.8	137.8 minutes Standard Deviation 68.4

SECONDARY outcome

Timeframe: On the day of index procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.

Outcome measures

Measure	Compassionate Use n=58 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=616 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=262 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Device Time	115.1 minutes Standard Deviation 65.6	96.6 minutes Standard Deviation 60.2	106.8 minutes Standard Deviation 58.2	111.5 minutes Standard Deviation 63.8

SECONDARY outcome

Timeframe: On the day of index procedure

Population: ITT population

Mean fluoroscopy duration during the MitraClip procedure.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=627 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=269 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Fluoroscopy Duration	42.5 minutes Standard Deviation 28.9	33.6 minutes Standard Deviation 21.3	38.5 minutes Standard Deviation 24.4	34.6 minutes Standard Deviation 20.0

SECONDARY outcome

Timeframe: On the day of index procedure

Population: ITT population

The distribution of number of MitraClip devices implanted in patients.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MitraClip Devices Implanted 3 Clips	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With MitraClip Devices Implanted 0 Clips	4 Participants	0 Participants	25 Participants	13 Participants
Number of Participants With MitraClip Devices Implanted 1 Clip	30 Participants	5 Participants	333 Participants	160 Participants
Number of Participants With MitraClip Devices Implanted 2 Clips	25 Participants	2 Participants	268 Participants	98 Participants

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure).

Population: ITT population

Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=270 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration	22.1 Hours Standard Deviation 29.9	149.3 Hours Standard Deviation 179.3	36.5 Hours Standard Deviation 70.3	28.8 Hours Standard Deviation 69.5

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure).

Population: ITT population

Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=627 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=270 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Post-Procedure Length of Hospital Stay	2.4 Days Standard Deviation 2.4	12.3 Days Standard Deviation 7.5	3.2 Days Standard Deviation 4.6	2.8 Days Standard Deviation 4.8

SECONDARY outcome

Timeframe: 12 months visit window (410 days)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Measure	Compassionate Use n=21 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=148 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=27 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants Experiencing Death Cardiac	13 Participants	2 Participants	97 Participants	13 Participants
Number of Participants Experiencing Death Non-Cardiac	7 Participants	3 Participants	49 Participants	14 Participants
Number of Participants Experiencing Death Not Adjudicated	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Experiencing Death Not Adjudicable	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure)

Population: ITT population

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Skilled nursing facility	3 Participants	4 Participants	34 Participants	3 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Long-term acute care	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Home with home health care	3 Participants	2 Participants	43 Participants	13 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Home	51 Participants	0 Participants	523 Participants	248 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Nursing home	0 Participants	0 Participants	15 Participants	3 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Death	1 Participants	1 Participants	12 Participants	2 Participants
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility Withdrawal	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population

Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Hospital Re-admissions	7 Participants	1 Participants	74 Participants	15 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: ITT population

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)	0 Participants	1 Participants	13 Participants	11 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL).

Outcome measures

Measure	Compassionate Use n=55 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=603 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=258 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Mitral Stenosis	3 Participants	0 Participants	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 30 days(Follow-up)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography.

MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use n=56 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=587 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=264 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Mitral Regurgitation (MR) Severity 0+: None	0 Participants	0 Participants	7 Participants	1 Participants
Number of Participants With Mitral Regurgitation (MR) Severity 1+: Mild	22 Participants	1 Participants	315 Participants	144 Participants
Number of Participants With Mitral Regurgitation (MR) Severity 2+: Moderate	20 Participants	1 Participants	206 Participants	90 Participants
Number of Participants With Mitral Regurgitation (MR) Severity 3+: Moderate to Severe	11 Participants	3 Participants	50 Participants	25 Participants
Number of Participants With Mitral Regurgitation (MR) Severity 4+: Severe	3 Participants	0 Participants	9 Participants	4 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use n=34 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=410 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=209 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MR Severity 0+: None	1 Participants	0 Participants	6 Participants	3 Participants
Number of Participants With MR Severity 1+: Mild	17 Participants	0 Participants	167 Participants	71 Participants
Number of Participants With MR Severity 2+: Moderate	10 Participants	0 Participants	173 Participants	100 Participants
Number of Participants With MR Severity 3+: Moderate to Severe	3 Participants	0 Participants	48 Participants	31 Participants
Number of Participants With MR Severity 4+: Severe	3 Participants	0 Participants	16 Participants	4 Participants

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use n=10 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=227 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=179 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MR Severity 0+: None	0 Participants	0 Participants	0 Participants	4 Participants
Number of Participants With MR Severity 1+: Mild	6 Participants	0 Participants	102 Participants	65 Participants
Number of Participants With MR Severity 2+: Moderate	3 Participants	0 Participants	90 Participants	87 Participants
Number of Participants With MR Severity 3+: Moderate to Severe	1 Participants	0 Participants	23 Participants	21 Participants
Number of Participants With MR Severity 4+: Severe	0 Participants	0 Participants	12 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use n=8 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=222 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=159 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MR Severity 0+: None	1 Participants	0 Participants	1 Participants	8 Participants
Number of Participants With MR Severity 1+: Mild	5 Participants	0 Participants	103 Participants	58 Participants
Number of Participants With MR Severity 2+: Moderate	2 Participants	0 Participants	90 Participants	73 Participants
Number of Participants With MR Severity 3+: Moderate to Severe	0 Participants	0 Participants	20 Participants	15 Participants
Number of Participants With MR Severity 4+: Severe	0 Participants	0 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The 4-year visit was optional and no data were collected at this time point for CU and EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.

Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=66 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=67 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MR Severity 1+: Mild	0 Participants	0 Participants	29 Participants	26 Participants
Number of Participants With MR Severity 0+: None	0 Participants	0 Participants	0 Participants	3 Participants
Number of Participants With MR Severity 2+: Moderate	0 Participants	0 Participants	32 Participants	22 Participants
Number of Participants With MR Severity 3+: Moderate to Severe	0 Participants	0 Participants	4 Participants	14 Participants
Number of Participants With MR Severity 4+: Severe	0 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 5 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.

Outcome measures

Measure	Compassionate Use n=5 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=108 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=117 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With MR Severity 0+:None	0 Participants	0 Participants	2 Participants	4 Participants
Number of Participants With MR Severity 1+:Mild	4 Participants	0 Participants	50 Participants	50 Participants
Number of Participants With MR Severity 2+:Moderate	1 Participants	0 Participants	43 Participants	48 Participants
Number of Participants With MR Severity 3+:Moderate to Severe	0 Participants	0 Participants	10 Participants	9 Participants
Number of Participants With MR Severity 4+:Severe	0 Participants	0 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 139 days post the index procedure

Population: ITT population

If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.	1 Participants	0 Participants	12 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT population

If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.

Outcome measures

Measure	Compassionate Use n=59 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=271 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.	1 Participants	0 Participants	33 Participants	11 Participants

SECONDARY outcome

Timeframe: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use n=50 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=3 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=560 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=252 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With New York Heart Association (NYHA) Functional Class NYHA Functional Class I	17 Participants	0 Participants	163 Participants	113 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class NYHA Functional Class II	22 Participants	2 Participants	296 Participants	110 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class NYHA Functional Class III	10 Participants	1 Participants	88 Participants	28 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class NYHA Functional Class IV	1 Participants	0 Participants	13 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use n=35 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=403 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=204 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With NYHA Functional Class NYHA Functional Class I	14 Participants	0 Participants	157 Participants	121 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class II	13 Participants	0 Participants	179 Participants	65 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class III	7 Participants	0 Participants	61 Participants	18 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class IV	1 Participants	0 Participants	6 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use n=23 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=293 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=182 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With NYHA Functional Class NYHA Functional Class I	6 Participants	0 Participants	113 Participants	99 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class II	11 Participants	0 Participants	126 Participants	68 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class III	5 Participants	0 Participants	49 Participants	14 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class IV	1 Participants	0 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use n=14 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=224 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=154 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With NYHA Functional Class NYHA Functional Class I	7 Participants	0 Participants	82 Participants	85 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class II	6 Participants	0 Participants	101 Participants	56 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class III	1 Participants	0 Participants	34 Participants	12 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class IV	0 Participants	0 Participants	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 years

Population: The 4-year visit was optional and no data were collected at this time point for CU and EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.

Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=105 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=125 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With NYHA Functional Class NYHA Functional Class I	0 Participants	0 Participants	44 Participants	76 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class II	0 Participants	0 Participants	47 Participants	35 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class III	0 Participants	0 Participants	14 Participants	11 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class IV	0 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 5 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	Compassionate Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=121 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=119 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Number of Participants With NYHA Functional Class NYHA Functional Class I	1 Participants	0 Participants	52 Participants	65 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class II	3 Participants	0 Participants	48 Participants	49 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class III	1 Participants	0 Participants	12 Participants	5 Participants
Number of Participants With NYHA Functional Class NYHA Functional Class IV	1 Participants	0 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=53 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=514 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=231 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	163.9 ml Standard Deviation 68.2	110.7 ml Standard Deviation 25.1	143.1 ml Standard Deviation 54.1	121.8 ml Standard Deviation 43.8

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=335 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=179 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	171.1 ml Standard Deviation 83.4	—	142.9 ml Standard Deviation 57.3	120.9 ml Standard Deviation 30.0

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=190 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=153 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	175.0 ml Standard Deviation 65.4	—	148.2 ml Standard Deviation 68.2	119.6 ml Standard Deviation 40.0

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=195 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=141 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	155.7 ml Standard Deviation 56.9	—	150.9 ml Standard Deviation 69.0	120.1 ml Standard Deviation 41.0

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=54 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=63 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	—	—	138.6 ml Standard Deviation 68.2	128.1 ml Standard Deviation 38.2

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=97 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=100 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-diastolic Volume (LVEDV)	—	—	146.1 ml Standard Deviation 71.4	125.9 ml Standard Deviation 45.6

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=53 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=513 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=231 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	94.7 ml Standard Deviation 58.9	46.3 ml Standard Deviation 21.5	82.9 ml Standard Deviation 44.7	59.4 ml Standard Deviation 31.9

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=354 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=179 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	102.2 ml Standard Deviation 71.8	—	80.4 ml Standard Deviation 48.6	57.6 ml Standard Deviation 29.5

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=189 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=153 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	98.7 ml Standard Deviation 56.0	—	85.9 ml Standard Deviation 59.0	57.1 ml Standard Deviation 32.6

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=194 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=141 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	97.0 ml Standard Deviation 52.5	—	88.8 ml Standard Deviation 60.2	55.8 ml Standard Deviation 32.2

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=54 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=63 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	—	—	77.8 ml Standard Deviation 61.6	55.3 ml Standard Deviation 26.5

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=97 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=100 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular End-systolic Volume (LVESV)	—	—	85.4 ml Standard Deviation 62.9	59.0 ml Standard Deviation 38.2

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=55 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=565 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=257 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.7 cm Standard Deviation 1.2	4.6 cm Standard Deviation 0.4	5.4 cm Standard Deviation 0.8	5.1 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=34 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=396 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=201 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.9 cm Standard Deviation 1.2	—	5.5 cm Standard Deviation 0.9	5.1 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=9 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=213 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=169 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.9 cm Standard Deviation 1.2	—	5.5 cm Standard Deviation 1.0	5.0 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=8 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=215 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=156 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.9 cm Standard Deviation 0.9	—	5.6 cm Standard Deviation 1.0	5.2 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=61 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=68 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	—	—	5.5 cm Standard Deviation 1.0	5.2 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=101 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=115 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Diastole (LVIDd)	—	—	5.4 cm Standard Deviation 1.0	5.3 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=55 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=542 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=242 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	4.5 cm Standard Deviation 1.5	2.9 cm Standard Deviation 0.5	4.3 cm Standard Deviation 1.1	3.7 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=34 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=377 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=189 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	4.7 cm Standard Deviation 1.5	—	4.2 cm Standard Deviation 1.1	3.6 cm Standard Deviation 0.9

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=9 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=200 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=147 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	4.3 cm Standard Deviation 1.6	—	4.3 cm Standard Deviation 1.2	3.6 cm Standard Deviation 0.9

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=8 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=209 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=143 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	4.7 cm Standard Deviation 1.3	—	4.4 cm Standard Deviation 1.3	3.6 cm Standard Deviation 1.0

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=58 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=67 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	—	—	4.1 cm Standard Deviation 1.4	3.6 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=101 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=110 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Internal Dimension Systole (LVIDs)	—	—	4.2 cm Standard Deviation 1.3	3.7 cm Standard Deviation 1.0

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=53 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=514 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=231 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	46.9 percentage of ejection fraction Standard Deviation 15.5	59.4 percentage of ejection fraction Standard Deviation 10.8	44.7 percentage of ejection fraction Standard Deviation 13.1	53.0 percentage of ejection fraction Standard Deviation 11.2

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=355 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=179 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	46.0 percentage of ejection fraction Standard Deviation 15.6	—	47.2 percentage of ejection fraction Standard Deviation 14.0	53.9 percentage of ejection fraction Standard Deviation 11.5

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=190 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=153 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	47.0 percentage of ejection fraction Standard Deviation 13.9	—	46.1 percentage of ejection fraction Standard Deviation 14.2	54.4 percentage of ejection fraction Standard Deviation 11.8

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=194 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=141 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	41.5 percentage of ejection fraction Standard Deviation 17.4	—	45.9 percentage of ejection fraction Standard Deviation 15.0	55.5 percentage of ejection fraction Standard Deviation 12.1

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=54 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=63 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	—	—	48.9 percentage of ejection fraction Standard Deviation 14.6	58.2 percentage of ejection fraction Standard Deviation 8.5

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=98 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=100 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Left Ventricular Ejection Fraction (LVEF)	—	—	46.3 percentage of ejection fraction Standard Deviation 14.6	55.5 percentage of ejection fraction Standard Deviation 11.4

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=50 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=479 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=216 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	4.1 cm Standard Deviation 0.5	3.7 cm Standard Deviation 0.5	3.8 cm Standard Deviation 0.5	3.8 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=324 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=160 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	3.9 cm Standard Deviation 0.4	—	3.8 cm Standard Deviation 0.5	3.8 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=8 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=173 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=133 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	3.9 cm Standard Deviation 0.2	—	3.8 cm Standard Deviation 0.5	3.8 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=189 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=126 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	4.0 cm Standard Deviation 0.3	—	3.9 cm Standard Deviation 0.5	4.0 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=53 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=56 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	—	—	4.0 cm Standard Deviation 0.5	4.1 cm Standard Deviation 0.6

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=86 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=99 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Diastole (SLADd)	—	—	3.9 cm Standard Deviation 0.5	4.0 cm Standard Deviation 0.6

SECONDARY outcome

Timeframe: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=50 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=6 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=472 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=212 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	3.5 cm Standard Deviation 0.4	3.3 cm Standard Deviation 0.6	3.4 cm Standard Deviation 0.5	3.5 cm Standard Deviation 0.4

SECONDARY outcome

Timeframe: 12 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=317 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=157 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	3.4 cm Standard Deviation 0.4	—	3.3 cm Standard Deviation 0.5	3.4 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=8 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=167 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=131 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	3.4 cm Standard Deviation 0.3	—	3.3 cm Standard Deviation 0.5	3.4 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 36 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use n=7 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=186 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=123 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	3.5 cm Standard Deviation 0.4	—	3.4 cm Standard Deviation 0.5	3.4 cm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 48 months

Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=53 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=55 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	—	—	3.4 cm Standard Deviation 0.5	3.5 cm Standard Deviation 0.6

SECONDARY outcome

Timeframe: 60 months

Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.

Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.

Outcome measures

Measure	Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=85 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk n=96 Participants Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Septal-Lateral Annular Dimension Systole (SLADs)	—	—	3.4 cm Standard Deviation 0.6	3.5 cm Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame.

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:

• Physical functioning
• Role limitations due to physical or
• Emotional health
• Bodily pain
• General health perceptions
• Vitality
• Social functioning
• General mental health

Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

Outcome measures

Measure	Compassionate Use n=44 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=500 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=93 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days Physical Component Summary	7.6 Scores on a scale Standard Deviation 9.6	38.3 Scores on a scale Standard Deviation 10.0	40.7 Scores on a scale Standard Deviation 9.6	—
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days Mental Component Summary	5.3 Scores on a scale Standard Deviation 11.3	49.3 Scores on a scale Standard Deviation 12.0	52.5 Scores on a scale Standard Deviation 10.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame.

The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:

• Physical functioning
• Role limitations due to physical or
• Emotional health
• Bodily pain
• General health perceptions
• Vitality
• Social functioning
• General mental health

Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.

The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

Outcome measures

Measure	Compassionate Use n=32 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=332 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=77 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months Physical Component Summary	7.2 Scores on a scale Standard Deviation 10.7	38.9 Scores on a scale Standard Deviation 10.6	43.2 Scores on a scale Standard Deviation 10.6	—
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months Mental Component Summary	6.7 Scores on a scale Standard Deviation 12.0	50.3 Scores on a scale Standard Deviation 11.9	51.3 Scores on a scale Standard Deviation 10.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline and 30 Days

Population: EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Outcome measures

Measure	Compassionate Use n=36 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=261 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=67 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Change in 6-Minute Walk Test (6MWT) Baseline	243.1 Meters Standard Deviation 124.6	237.8 Meters Standard Deviation 141.9	386.7 Meters Standard Deviation 396.8	—
Change in 6-Minute Walk Test (6MWT) 30 Days	296.6 Meters Standard Deviation 186.8	278.8 Meters Standard Deviation 162.7	428.9 Meters Standard Deviation 296.4	—
Change in 6-Minute Walk Test (6MWT) Difference	53.4 Meters Standard Deviation 131.4	40.9 Meters Standard Deviation 108.6	42.1 Meters Standard Deviation 293.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline and 6 months

Population: EU and CU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 6 months were not available for EU and CU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame HR and Non-HR arms.

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Outcome measures

Measure	Compassionate Use n=198 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=62 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Change in 6-Minute Walk Test (6MWT) Baseline	252.0 Meters Standard Deviation 142.5	413.6 Meters Standard Deviation 406.4	—	—
Change in 6-Minute Walk Test (6MWT) 6 Months	283.8 Meters Standard Deviation 147.9	392.8 Meters Standard Deviation 245.1	—	—
Change in 6-Minute Walk Test (6MWT) Difference	31.8 Meters Standard Deviation 134.7	-20.9 Meters Standard Deviation 333.2	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline and 12 months

Population: EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.

Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.

Outcome measures

Measure	Compassionate Use n=25 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Emergency Use n=172 Participants Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=57 Participants Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high RIsk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Change in 6-Minute Walk Test (6MWT) Baseline	267.4 Meters Standard Deviation 115.3	261.4 Meters Standard Deviation 142.2	408.8 Meters Standard Deviation 380.3	—
Change in 6-Minute Walk Test (6MWT) 12 Months	291.4 Meters Standard Deviation 142.0	296.6 Meters Standard Deviation 129.9	392.6 Meters Standard Deviation 211.1	—
Change in 6-Minute Walk Test (6MWT) Difference	24.0 Meters Standard Deviation 112.8	35.2 Meters Standard Deviation 155.7	-16.2 Meters Standard Deviation 339.8	—

Adverse Events

Compassionate Use

Serious events: 49 serious events

Other events: 39 other events

Deaths: 42 deaths

Emergency Use

Serious events: 7 serious events

Other events: 4 other events

Deaths: 7 deaths

High Risk

Serious events: 542 serious events

Other events: 503 other events

Deaths: 379 deaths

Non-high Risk

Serious events: 208 serious events

Other events: 225 other events

Deaths: 96 deaths

Serious adverse events

Measure	Compassionate Use n=59 participants at risk Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant	Emergency Use n=7 participants at risk Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 participants at risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high Risk n=271 participants at risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Blood and lymphatic system disorders Anemia	5.1% 3/59 • 5 years	14.3% 1/7 • 5 years	7.8% 49/628 • 5 years	8.5% 23/271 • 5 years
Blood and lymphatic system disorders Hematologic - Other	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.00% 0/271 • 5 years
Blood and lymphatic system disorders Infection	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	0.00% 0/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Atrial arrhythmia	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	6.8% 43/628 • 5 years	12.9% 35/271 • 5 years
Cardiac disorders Atrial septal defect	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.4% 9/628 • 5 years	0.74% 2/271 • 5 years
Cardiac disorders Cardiac : other	3.4% 2/59 • 5 years	14.3% 1/7 • 5 years	4.1% 26/628 • 5 years	3.3% 9/271 • 5 years
Cardiac disorders Cardiac arrest	8.5% 5/59 • 5 years	0.00% 0/7 • 5 years	6.8% 43/628 • 5 years	3.3% 9/271 • 5 years
Cardiac disorders Cardiogenic shock	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	2.4% 15/628 • 5 years	1.8% 5/271 • 5 years
Cardiac disorders Cardiomyopathy	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.9% 12/628 • 5 years	1.1% 3/271 • 5 years
Cardiac disorders Chest pain	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	4.9% 31/628 • 5 years	4.1% 11/271 • 5 years
Cardiac disorders Congestive heart failure	22.0% 13/59 • 5 years	42.9% 3/7 • 5 years	36.9% 232/628 • 5 years	23.2% 63/271 • 5 years
Cardiac disorders Endocarditis	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.80% 5/628 • 5 years	1.5% 4/271 • 5 years
Cardiac disorders Lead displacement	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Mitral stenosis	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.74% 2/271 • 5 years
Cardiac disorders Myocardial infarction	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	4.1% 26/628 • 5 years	2.6% 7/271 • 5 years
Cardiac disorders Other rhythm disorder	5.1% 3/59 • 5 years	0.00% 0/7 • 5 years	4.0% 25/628 • 5 years	1.8% 5/271 • 5 years
Cardiac disorders Residual/Recurrent MR	5.1% 3/59 • 5 years	14.3% 1/7 • 5 years	5.6% 35/628 • 5 years	9.6% 26/271 • 5 years
Cardiac disorders Syncope/Dizziness	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.8% 24/628 • 5 years	1.8% 5/271 • 5 years
Cardiac disorders Tamponade	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.74% 2/271 • 5 years
Cardiac disorders Ventricular arrhythmia	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	4.6% 29/628 • 5 years	1.8% 5/271 • 5 years
Gastrointestinal disorders GI related - bleed	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	8.9% 56/628 • 5 years	10.7% 29/271 • 5 years
Gastrointestinal disorders GI related - infection	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	1.4% 9/628 • 5 years	2.6% 7/271 • 5 years
Gastrointestinal disorders GI related - other	11.9% 7/59 • 5 years	28.6% 2/7 • 5 years	10.4% 65/628 • 5 years	8.5% 23/271 • 5 years
General disorders Death	57.6% 34/59 • 5 years	100.0% 7/7 • 5 years	56.1% 352/628 • 5 years	35.1% 95/271 • 5 years
General disorders Generalized weakness/fatigue	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	2.2% 6/271 • 5 years
General disorders Metabolic/endocrine disorders : Other	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	6.5% 41/628 • 5 years	8.9% 24/271 • 5 years
General disorders Other	11.9% 7/59 • 5 years	0.00% 0/7 • 5 years	11.6% 73/628 • 5 years	12.5% 34/271 • 5 years
General disorders device malfunction	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.00% 0/271 • 5 years
General disorders infection : Other	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	3.7% 23/628 • 5 years	3.7% 10/271 • 5 years
Musculoskeletal and connective tissue disorders Connective tissue disorders	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	9.1% 57/628 • 5 years	11.1% 30/271 • 5 years
Nervous system disorders Intracerebral hemorrhage	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	2.4% 15/628 • 5 years	1.1% 3/271 • 5 years
Nervous system disorders Ischemic stroke	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	1.5% 4/271 • 5 years
Nervous system disorders Neurologic - other	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	2.6% 7/271 • 5 years
Nervous system disorders Stroke	8.5% 5/59 • 5 years	0.00% 0/7 • 5 years	3.7% 23/628 • 5 years	5.9% 16/271 • 5 years
Psychiatric disorders Mental disorders : Other	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.00% 0/271 • 5 years
Renal and urinary disorders Renal - infection	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	3.3% 9/271 • 5 years
Renal and urinary disorders Renal - other	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	3.7% 23/628 • 5 years	2.2% 6/271 • 5 years
Renal and urinary disorders Renal - renal insufficiency/failure	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	12.4% 78/628 • 5 years	9.2% 25/271 • 5 years
Respiratory, thoracic and mediastinal disorders Bronchial/lung disorders	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.7% 23/628 • 5 years	2.2% 6/271 • 5 years
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary diseas	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	2.4% 15/628 • 5 years	3.0% 8/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	4.1% 26/628 • 5 years	2.6% 7/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	10.0% 63/628 • 5 years	12.2% 33/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	1.5% 4/271 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory - other	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	7.3% 46/628 • 5 years	6.6% 18/271 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.2% 6/59 • 5 years	42.9% 3/7 • 5 years	8.9% 56/628 • 5 years	9.6% 26/271 • 5 years
Vascular disorders Bleeding complication	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	5.1% 32/628 • 5 years	3.7% 10/271 • 5 years
Vascular disorders Blood pressure complication	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.80% 5/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Deep vein thrombosis (DVT)	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.4% 9/628 • 5 years	1.1% 3/271 • 5 years
Vascular disorders Embolization	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Hematoma	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.9% 12/628 • 5 years	2.2% 6/271 • 5 years
Vascular disorders Hemodynamic instability	3.4% 2/59 • 5 years	14.3% 1/7 • 5 years	4.5% 28/628 • 5 years	2.2% 6/271 • 5 years
Vascular disorders Injury	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Pseudoaneurysm	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Vascular - other	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.9% 12/628 • 5 years	3.3% 9/271 • 5 years
Blood and lymphatic system disorders Coagulopathy	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.9% 12/628 • 5 years	1.8% 5/271 • 5 years
Blood and lymphatic system disorders Infection/bacteremia/septicemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	7.2% 45/628 • 5 years	7.0% 19/271 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	1.5% 4/271 • 5 years
General disorders Fever	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.80% 5/628 • 5 years	1.1% 3/271 • 5 years
Skin and subcutaneous tissue disorders Skin/mucosal/subcutaneous tissue disorders	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.74% 2/271 • 5 years
Respiratory, thoracic and mediastinal disorders Hemothorax	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.37% 1/271 • 5 years
Respiratory, thoracic and mediastinal disorders Infection	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.37% 1/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	1.1% 3/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.3% 8/628 • 5 years	1.8% 5/271 • 5 years
Vascular disorders AV fistula	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.74% 2/271 • 5 years
Vascular disorders Peripheral Ischemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.74% 2/271 • 5 years
Vascular disorders Bruise/contusion/ecchymosis	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Vascular disorders Retroperitoneal hematoma	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Stenosis	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.00% 0/271 • 5 years
Nervous system disorders Transient Ischemic Attack (TIA)	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	4.1% 26/628 • 5 years	1.1% 3/271 • 5 years
Cardiac disorders MV Surgery	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	1.8% 5/271 • 5 years
Cardiac disorders SLDA	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	2.2% 6/271 • 5 years
Cardiac disorders Coronary artery disease	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.80% 5/628 • 5 years	0.74% 2/271 • 5 years
Cardiac disorders Heart transplant	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Left ventricular dysfunction	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Mitral valve injury	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Myocardial ischemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Palpitations	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Pericardial effusion	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	1.8% 5/271 • 5 years
Cardiac disorders peripheral edema	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Supraventricular arrhythmia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Thrombus	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	1.5% 4/271 • 5 years
Gastrointestinal disorders Abdominal pain	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.1% 7/628 • 5 years	0.74% 2/271 • 5 years
Gastrointestinal disorders Dysphagia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Bradyarrythmia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.6% 10/628 • 5 years	1.5% 4/271 • 5 years
Cardiac disorders Emergent MV surgery	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.74% 2/271 • 5 years
Blood and lymphatic system disorders Hematologic-Shock	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Mesentric Ischemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Thrombosis	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Heart Block	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.74% 2/271 • 5 years

Other adverse events

Measure	Compassionate Use n=59 participants at risk Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. MitraClip® implant: Percutaneous mitral valve repair using MitraClip implant	Emergency Use n=7 participants at risk Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	High Risk n=628 participants at risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.	Non-high Risk n=271 participants at risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant.
Cardiac disorders Bradyarrhythmia	5.1% 3/59 • 5 years	14.3% 1/7 • 5 years	3.0% 19/628 • 5 years	2.6% 7/271 • 5 years
Cardiac disorders Cardiomyopathy	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.80% 5/628 • 5 years	0.74% 2/271 • 5 years
Cardiac disorders Chest Pain/Angina	5.1% 3/59 • 5 years	0.00% 0/7 • 5 years	5.9% 37/628 • 5 years	5.5% 15/271 • 5 years
Cardiac disorders Congestive Heart Failure	10.2% 6/59 • 5 years	0.00% 0/7 • 5 years	10.2% 64/628 • 5 years	8.9% 24/271 • 5 years
Cardiac disorders Lead Displacement	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Left Ventricular Dysfunction	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.5% 22/628 • 5 years	2.2% 6/271 • 5 years
Cardiac disorders Mitral Stenosis	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	4.1% 26/628 • 5 years	3.0% 8/271 • 5 years
Cardiac disorders Mitral Valve Injury	0.00% 0/59 • 5 years	14.3% 1/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Other	5.1% 3/59 • 5 years	0.00% 0/7 • 5 years	6.8% 43/628 • 5 years	7.4% 20/271 • 5 years
Cardiac disorders Other Rhythm Disorder	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	3.8% 24/628 • 5 years	4.4% 12/271 • 5 years
Cardiac disorders Palpitations	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	1.1% 7/628 • 5 years	1.5% 4/271 • 5 years
Blood and lymphatic system disorders Anemia	8.5% 5/59 • 5 years	14.3% 1/7 • 5 years	11.0% 69/628 • 5 years	11.8% 32/271 • 5 years
Blood and lymphatic system disorders Infection/Bacteremia/Septicemia	1.7% 1/59 • 5 years	14.3% 1/7 • 5 years	1.1% 7/628 • 5 years	1.1% 3/271 • 5 years
Blood and lymphatic system disorders Other	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	1.3% 8/628 • 5 years	1.8% 5/271 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/59 • 5 years	14.3% 1/7 • 5 years	3.5% 22/628 • 5 years	3.7% 10/271 • 5 years
Cardiac disorders Atrial Arrhythmia	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	9.6% 60/628 • 5 years	12.5% 34/271 • 5 years
Cardiac disorders Atrial Septal Defect	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	2.1% 13/628 • 5 years	4.4% 12/271 • 5 years
Cardiac disorders Pericardial Effusion	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	1.3% 8/628 • 5 years	5.9% 16/271 • 5 years
Cardiac disorders Peripheral Edema	5.1% 3/59 • 5 years	14.3% 1/7 • 5 years	5.3% 33/628 • 5 years	6.6% 18/271 • 5 years
Cardiac disorders Residual/Recurrent MR	6.8% 4/59 • 5 years	14.3% 1/7 • 5 years	16.4% 103/628 • 5 years	20.3% 55/271 • 5 years
Cardiac disorders SLDA	0.00% 0/59 • 5 years	14.3% 1/7 • 5 years	0.32% 2/628 • 5 years	1.1% 3/271 • 5 years
Cardiac disorders Syncope/Dizziness	5.1% 3/59 • 5 years	0.00% 0/7 • 5 years	4.1% 26/628 • 5 years	6.6% 18/271 • 5 years
Cardiac disorders Thrombus	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Ventricular Arrhythmia	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	2.7% 17/628 • 5 years	2.2% 6/271 • 5 years
Gastrointestinal disorders Abdominal Pain	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.3% 21/628 • 5 years	1.8% 5/271 • 5 years
Gastrointestinal disorders Bleed	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	2.9% 18/628 • 5 years	4.1% 11/271 • 5 years
Gastrointestinal disorders Dysphagia	1.7% 1/59 • 5 years	28.6% 2/7 • 5 years	2.5% 16/628 • 5 years	2.6% 7/271 • 5 years
Gastrointestinal disorders Other	5.1% 3/59 • 5 years	28.6% 2/7 • 5 years	13.5% 85/628 • 5 years	16.2% 44/271 • 5 years
General disorders Death	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
General disorders Fever	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.0% 19/628 • 5 years	1.5% 4/271 • 5 years
General disorders Generalized Weakness/Fatigue	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	8.1% 51/628 • 5 years	6.3% 17/271 • 5 years
General disorders Infection	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	2.9% 18/628 • 5 years	2.6% 7/271 • 5 years
General disorders Mental Disorders	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	2.2% 14/628 • 5 years	2.2% 6/271 • 5 years
General disorders Metabolic/Endocrine Disorders	8.5% 5/59 • 5 years	0.00% 0/7 • 5 years	11.1% 70/628 • 5 years	12.9% 35/271 • 5 years
General disorders Other	11.9% 7/59 • 5 years	14.3% 1/7 • 5 years	22.5% 141/628 • 5 years	22.9% 62/271 • 5 years
Musculoskeletal and connective tissue disorders Connective Tissue Disorders	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	14.5% 91/628 • 5 years	20.3% 55/271 • 5 years
Nervous system disorders Confusion	0.00% 0/59 • 5 years	14.3% 1/7 • 5 years	0.00% 0/628 • 5 years	0.00% 0/271 • 5 years
Nervous system disorders Delirium	0.00% 0/59 • 5 years	14.3% 1/7 • 5 years	0.00% 0/628 • 5 years	0.00% 0/271 • 5 years
Nervous system disorders Other	8.5% 5/59 • 5 years	28.6% 2/7 • 5 years	8.4% 53/628 • 5 years	5.5% 15/271 • 5 years
Renal and urinary disorders Infection	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	8.4% 53/628 • 5 years	6.6% 18/271 • 5 years
Renal and urinary disorders Other	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	9.2% 58/628 • 5 years	8.1% 22/271 • 5 years
Renal and urinary disorders Renal Insufficiency/Failure	13.6% 8/59 • 5 years	0.00% 0/7 • 5 years	10.5% 66/628 • 5 years	9.6% 26/271 • 5 years
Respiratory, thoracic and mediastinal disorders Bronchial/Lung Disorders	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	4.1% 11/271 • 5 years
Respiratory, thoracic and mediastinal disorders Infection	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	4.1% 11/271 • 5 years
Respiratory, thoracic and mediastinal disorders Other	8.5% 5/59 • 5 years	14.3% 1/7 • 5 years	18.3% 115/628 • 5 years	24.4% 66/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	5.4% 34/628 • 5 years	8.9% 24/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	1.7% 1/59 • 5 years	14.3% 1/7 • 5 years	3.8% 24/628 • 5 years	4.8% 13/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.74% 2/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	1.1% 3/271 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory Failure	5.1% 3/59 • 5 years	0.00% 0/7 • 5 years	1.4% 9/628 • 5 years	1.8% 5/271 • 5 years
Vascular disorders AV fistula	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	1.1% 3/271 • 5 years
Vascular disorders Aneurysm	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Bleeding Complication	16.9% 10/59 • 5 years	0.00% 0/7 • 5 years	11.9% 75/628 • 5 years	10.7% 29/271 • 5 years
Vascular disorders Blood Pressure Complication	3.4% 2/59 • 5 years	0.00% 0/7 • 5 years	2.4% 15/628 • 5 years	4.4% 12/271 • 5 years
Vascular disorders DVT	1.7% 1/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	0.74% 2/271 • 5 years
Vascular disorders Hematoma	6.8% 4/59 • 5 years	0.00% 0/7 • 5 years	8.8% 55/628 • 5 years	5.5% 15/271 • 5 years
Vascular disorders Hemodynamic Instability	11.9% 7/59 • 5 years	14.3% 1/7 • 5 years	11.3% 71/628 • 5 years	10.3% 28/271 • 5 years
Cardiac disorders Cardiac arrest	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Coronary artery disease	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Endocarditis	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Cardiac disorders Heart block	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	1.1% 3/271 • 5 years
Cardiac disorders Myocardial infarction	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders Myocardial ischemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.96% 6/628 • 5 years	1.5% 4/271 • 5 years
Cardiac disorders Supraventricular arrhythmia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	1.1% 3/271 • 5 years
Cardiac disorders Surgery	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Gastrointestinal disorders Infection	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.4% 9/628 • 5 years	2.2% 6/271 • 5 years
Gastrointestinal disorders Nausea	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.48% 3/628 • 5 years	0.00% 0/271 • 5 years
Blood and lymphatic system disorders Coagulopathy	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.3% 8/628 • 5 years	1.1% 3/271 • 5 years
Nervous system disorders Transient Ischemic Attack (TIA)	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	2.1% 13/628 • 5 years	3.3% 9/271 • 5 years
Nervous system disorders Intracerebral hemorrhage	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.00% 0/271 • 5 years
Nervous system disorders Ischemic stroke	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.00% 0/271 • 5 years
Nervous system disorders Stroke	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.74% 2/271 • 5 years
General disorders Incisional site pain	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	4.8% 13/271 • 5 years
Skin and subcutaneous tissue disorders Skin/mucosal/subcutaneous tissue disorders	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.8% 11/628 • 5 years	3.0% 8/271 • 5 years
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease (COPD)	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.74% 2/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	1.1% 7/628 • 5 years	2.6% 7/271 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Vascular disorders Peripheral Ischemia	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Bruise/contusion/ecchymosis	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	3.2% 20/628 • 5 years	5.2% 14/271 • 5 years
Vascular disorders Injury	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Vascular disorders Other	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	2.4% 15/628 • 5 years	4.4% 12/271 • 5 years
Vascular disorders Pseudoaneurysm	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.32% 2/628 • 5 years	1.1% 3/271 • 5 years
Vascular disorders Thrombosis/Thromboembolism	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.64% 4/628 • 5 years	0.37% 1/271 • 5 years
Vascular disorders Thrombus	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.16% 1/628 • 5 years	0.00% 0/271 • 5 years
Vascular disorders Retroperitoneal hematoma	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.37% 1/271 • 5 years
Cardiac disorders MV surgery	0.00% 0/59 • 5 years	0.00% 0/7 • 5 years	0.00% 0/628 • 5 years	0.74% 2/271 • 5 years

Additional Information

Jeffrey T Ellis

Abbott Vascular

Email: jeffrey.ellis@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60