Trial Outcomes & Findings for ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe (NCT NCT01288976)
NCT ID: NCT01288976
Last Updated: 2018-11-07
Results Overview
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
COMPLETED
721 participants
At baseline
2018-11-07
Participant Flow
The ACCESS-EU Phase I Study began enrolling patients in October 2, 2008 and completed enrollment on April 13, 2011. There were 567 patients enrolled at 14 investigational sites in Europe. The last follow-up visit occurred on June 15, 2012 and the last monitoring visit occurred August 9, 2012.
Participant milestones
| Measure |
MitraClip Therapy
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
Medical Management
Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
|
Mitral Valve Surgery
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
|
|---|---|---|---|
|
Overall Study
STARTED
|
567
|
49
|
105
|
|
Overall Study
COMPLETED
|
389
|
22
|
85
|
|
Overall Study
NOT COMPLETED
|
178
|
27
|
20
|
Reasons for withdrawal
| Measure |
MitraClip Therapy
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
Medical Management
Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
|
Mitral Valve Surgery
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
58
|
12
|
9
|
|
Overall Study
Death
|
98
|
6
|
4
|
|
Overall Study
Data unavailable
|
22
|
9
|
7
|
Baseline Characteristics
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
Baseline characteristics by cohort
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
Medical Management
n=49 Participants
Patients with MR managed nonsurgically based on standard hospital clinical practice. Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
|
Mitral Valve Surgery
n=105 Participants
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
|
Total
n=721 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
362 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
447 Participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
567 participants
n=5 Participants
|
49 participants
n=7 Participants
|
105 participants
n=5 Participants
|
721 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at baseline.
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Outcome measures
| Measure |
MitraClip Therapy
n=327 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
MR Severity
2+ to 3+: Moderate to Moderate-to-Severe
|
9.2 percentage of participants
|
|
MR Severity
3+:Moderate-to-Severe
|
35.8 percentage of participants
|
|
MR Severity
0:None
|
0.0 percentage of participants
|
|
MR Severity
1+:Mild
|
0.0 percentage of participants
|
|
MR Severity
1+ to 2+: Mild-to-Moderate
|
0.0 percentage of participants
|
|
MR Severity
2+:Moderate
|
3.1 percentage of participants
|
|
MR Severity
3+ to 4+: Moderate-to-Severe to Severe
|
21.7 percentage of participants
|
|
MR Severity
4+:Severe
|
30.3 percentage of participants
|
PRIMARY outcome
Timeframe: At 12 monthsPopulation: MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at 12 months.
MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Outcome measures
| Measure |
MitraClip Therapy
n=327 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
MR Severity
0:None
|
2.8 percentage of participants
|
|
MR Severity
1+:Mild
|
27.8 percentage of participants
|
|
MR Severity
1+ to 2+: Mild-to-Moderate
|
15.0 percentage of participants
|
|
MR Severity
2+: Moderate
|
33.3 percentage of participants
|
|
MR Severity
2+ to 3+: Moderate to Moderate-to-Severe
|
9.8 percentage of participants
|
|
MR Severity
3+: Moderate-to-Severe
|
6.7 percentage of participants
|
|
MR Severity
3+ to 4+: Moderate-to-Severe to Severe
|
1.5 percentage of participants
|
|
MR Severity
4+: Severe
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (On the day of procedure)Population: Procedure time is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Procedure Time was not recorded for 196 of 567 patients.Therefore, the data is available for 371 patients.
Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Outcome measures
| Measure |
MitraClip Therapy
n=371 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Procedure Time
|
116.9 Minutes
Standard Deviation 68.1
|
SECONDARY outcome
Timeframe: Day 0 (On the day of procedure)Population: Contrast volume is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Contrast volume was not recorded for 9 of 567 patients. Therefore, Contrast volume is available for 558 subjects.
Outcome measures
| Measure |
MitraClip Therapy
n=558 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Contrast Volume
|
17.0 milliliter
Standard Deviation 39.7
|
SECONDARY outcome
Timeframe: Day 0 (On the day of procedure)Population: Fluoroscopy duration is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups Fluoroscopy duration was not recorded for 99 of 567 patients. Therefore, Fluoroscopy duration is available for 468 patients
Outcome measures
| Measure |
MitraClip Therapy
n=468 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Fluoroscopy Duration
|
29.1 Minutes
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Day 0 (On the day of procedure)Population: Number of MitraClip Devices Implanted is reported only for patients who underwent the MitraClip procedure.The Medical Therapy\&Mitral Valve Surgery comparator groups were followed\&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Number of MitraClip Devices Implanted
0 MitraClip Devices
|
0.4 percentage of participants
|
|
Number of MitraClip Devices Implanted
1 MitraClip Devices
|
60.1 percentage of participants
|
|
Number of MitraClip Devices Implanted
2 MitraClip Devices
|
36.7 percentage of participants
|
|
Number of MitraClip Devices Implanted
3 MitraClip Devices
|
2.6 percentage of participants
|
|
Number of MitraClip Devices Implanted
4 MitraClip Devices
|
0.2 percentage of participants
|
SECONDARY outcome
Timeframe: From the day of procedure throughout 12 months of study periodPopulation: ICU and Hospital Stay is reported only for patients who underwent the MitraClip procedure.The Medical Therapy\&Mitral Valve Surgery comparator groups were followed\&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
ICU and Hospital Stay
Post-procedure ICU/CCU/PACU Duration (n=567)
|
2.5 Days
Standard Deviation 6.5
|
|
ICU and Hospital Stay
Post-procedure hospital stay (n=564)
|
7.7 Days
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: At discharge, an average of 7.7 days following the MitraClip procedurePopulation: Discharge Status and Facility is reported only for patients who underwent the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.Discharge Status and Facility outcomes data is available for 563 patients.
Outcome measures
| Measure |
MitraClip Therapy
n=563 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Discharge Status and Facility
Death
|
2.0 percentage of participants
|
|
Discharge Status and Facility
Home without home health care
|
79.2 percentage of participants
|
|
Discharge Status and Facility
Home with home health care
|
0.4 percentage of participants
|
|
Discharge Status and Facility
Skilled nursing facility/ Hospital
|
17.1 percentage of participants
|
|
Discharge Status and Facility
Nursing home
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: At discharge, an average of 7.7 days following the MitraClip procedurePopulation: MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups.MR severity will not be reported for these comparator arms. A total of 521 MitraClip patients analyzed.Missing data is due to death(n=11),patient withdrawal(n=13),data unavailable(n=3),discharge echocardiogram not done/missing(n=19).
Outcome measures
| Measure |
MitraClip Therapy
n=521 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Discharge MR Severity
0:None
|
4.4 percentage of participants
|
|
Discharge MR Severity
1+:Mild
|
46.4 percentage of participants
|
|
Discharge MR Severity
1+ to 2+: Mild-to-Moderate
|
14.0 percentage of participants
|
|
Discharge MR Severity
2+:Moderate
|
26.3 percentage of participants
|
|
Discharge MR Severity
2+ to 3+:Moderate to Moderate-to-Severe
|
4.4 percentage of participants
|
|
Discharge MR Severity
3+:Moderate-to-Severe
|
3.1 percentage of participants
|
|
Discharge MR Severity
3+ to 4+:Moderate-to-Severe to Severe
|
1.0 percentage of participants
|
|
Discharge MR Severity
4+:Severe
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: At 0 dayPopulation: Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed\&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Kaplan-Meier Freedom From All-Cause Mortality
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: At 30 daysPopulation: Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Kaplan-Meier Freedom From All-Cause Mortality
|
96.6 percentage of participants
Interval 94.7 to 97.8
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Kaplan-Meier Freedom From All-Cause Mortality
|
88.2 percentage of participants
Interval 85.1 to 90.6
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Kaplan-Meier Freedom From All-Cause Mortality
|
81.8 percentage of participants
Interval 78.1 to 84.8
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: Device Embolization and Single Leaflet Device Attachment are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.
Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Device Embolization and Single Leaflet Device Attachment
Device embolization
|
0 participants
|
|
Device Embolization and Single Leaflet Device Attachment
SLDA
|
27 participants
|
SECONDARY outcome
Timeframe: On day 1 post procedurePopulation: 1-Day Post-Procedure Safety Outcomes are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups
This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy\&Mitral Valve Surgery comparator groups were followed\&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
1-Day Post-Procedure Safety Outcomes
Death
|
0 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Stroke
|
0 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Myocardial Infarction
|
0.2 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Respiratory Failure
|
0 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Need for Resuscitation
|
1.1 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Cardiac Tamponade
|
0.9 percentage of participants
|
|
1-Day Post-Procedure Safety Outcomes
Mitral Valve Surgery
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: This outcome measure is reported only for the MitraClip device group. The need for mitral valve surgery was not captured in the Medical Management or the Mitral Valve Surgery groups.
This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure.
Outcome measures
| Measure |
MitraClip Therapy
n=567 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Need for Mitral Valve Surgery
|
6.3 percentage of participants
|
SECONDARY outcome
Timeframe: At baselinePopulation: NYHA Functional Class was not consistently captured for patients in the Medical Management\&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.A total of 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .
New York Heart Association (NYHA) Functional Classification. 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 |
MitraClip Therapy
n=343 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
NYHA Functional Class
NYHA I
|
1.7 percentage of participants
|
|
NYHA Functional Class
NYHA II
|
16 percentage of participants
|
|
NYHA Functional Class
NYHA III
|
72.3 percentage of participants
|
|
NYHA Functional Class
NYHA IV
|
9.9 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 monthPopulation: NYHA Functional Class was not consistently captured for patients in the Medical Management\&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.Of total 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .
Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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/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/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 |
MitraClip Therapy
n=343 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
NYHA Functional Class
NYHA I
|
25.1 percentage of participants
|
|
NYHA Functional Class
NYHA II
|
46.4 percentage of participants
|
|
NYHA Functional Class
NYHA III
|
26.8 percentage of participants
|
|
NYHA Functional Class
NYHA IV
|
1.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: The 6-minute walk test was not consistently captured for patients in the Medical Management\&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22\&173 patients did not perform the 6-minute walk test. .
The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline.
Outcome measures
| Measure |
MitraClip Therapy
n=216 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
Baseline
|
274.7 meters
Standard Deviation 118.7
|
|
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
12 months
|
334.2 meters
Standard Deviation 127.9
|
|
The Change in 6 Minute Walk Test Distance From Baseline to 12 Months
Improvement from Baseline to 12 Months
|
59.5 meters
Standard Deviation 112.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The MLWHF Questionnaire was not consistently administered to patients in the Medical Management\&Mitral Valve Surgery groups.Thus MLWHF will not be reported for these comparator arms.Of the 567 MitraClip device patients,264 analyzed due to death:98,withdrew consent:58,lost to follow-up:22\&125 patients did not complete MLWHF Questionnaire.
The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower\&higher MLHFQ score indicates less effect of heart failure\&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)\&c) other factors,measured using 8 questions (possible subscale score from 0-40).
Outcome measures
| Measure |
MitraClip Therapy
n=264 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
Baseline
|
41.6 Quality of Life Score
Standard Deviation 18.9
|
|
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
12 months
|
28.1 Quality of Life Score
Standard Deviation 20.1
|
|
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months
Difference (12 Months - Baseline)
|
-13.5 Quality of Life Score
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: The 6-minute walk test was not consistently captured for patients in the Medical Management\&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22\&173 patients did not perform the 6-minute walk test at baseline. .
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
Outcome measures
| Measure |
MitraClip Therapy
n=216 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Six Minute Walk Test Distance (6MWT)
|
274.7 meters
Standard Deviation 118.7
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The 6-MWT was not consistently captured for patients in the Medical Management\&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22\&173 patients did not perform the 6-minute walk test at the12 month visit. .
The 6-minute walk distance test will be used to measure the patient's exercise capacity.
Outcome measures
| Measure |
MitraClip Therapy
n=216 Participants
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
|---|---|
|
Six Minute Walk Test Distance (6MWT)
|
334.2 meters
Standard Deviation 127.9
|
Adverse Events
MitraClip Therapy
Medical Management
Mitral Valve Surgery
Serious adverse events
| Measure |
MitraClip Therapy
n=567 participants at risk
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
Medical Management
n=49 participants at risk
Patients with MR managed nonsurgically based on standard hospital clinical practice.
Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
|
Mitral Valve Surgery
n=105 participants at risk
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Septal Defect (ASD)
|
2.6%
15/567 • Number of events 16 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Arteriovenous (AV) fistula Fistula
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Atrioventricular block (AV block)
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.1%
57/567 • Number of events 69 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
7.6%
8/105 • Number of events 8 • 12 months
|
|
Cardiac disorders
Angina
|
2.3%
13/567 • Number of events 14 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Aortic Valve
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Arrhythmia, Other
|
4.6%
26/567 • Number of events 26 • 12 months
|
8.2%
4/49 • Number of events 5 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Cardiac disorders
Arrhythmias
|
2.3%
13/567 • Number of events 15 • 12 months
|
0.00%
0/49 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Ascites
|
1.6%
9/567 • Number of events 12 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Atrial arrhythmias
|
7.9%
45/567 • Number of events 55 • 12 months
|
10.2%
5/49 • Number of events 6 • 12 months
|
19.0%
20/105 • Number of events 25 • 12 months
|
|
Infections and infestations
Bacteremia/Septicemea
|
2.1%
12/567 • Number of events 12 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Bleeding complications
|
4.6%
26/567 • Number of events 26 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Vascular disorders
Blood pressure complications
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Bone and Joint Injuries
|
1.2%
7/567 • Number of events 9 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Breathing abnormalities
|
13.4%
76/567 • Number of events 94 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial and Lung disorders
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Bruise/Contusion/Ecchymosis
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Coronary artery disease (CAD)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
1.2%
7/567 • Number of events 8 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiac: Other
|
5.5%
31/567 • Number of events 32 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.88%
5/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Cardiomyopathy
|
2.5%
14/567 • Number of events 14 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Nervous system disorders
Cerebro-vascular : Other
|
1.8%
10/567 • Number of events 10 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Circulatory collapse
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
2.9%
3/105 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Coagulopathology
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Cough (non-productive)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Death
|
2.3%
13/567 • Number of events 13 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Device complications
|
3.2%
18/567 • Number of events 19 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Edema
|
7.9%
45/567 • Number of events 49 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Endocarditis
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Epidermal and dermal conditions
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Epistaxis
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Esophageal injury
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Eye disorders
Eye disorders
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Fever
|
2.1%
12/567 • Number of events 12 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) hemorrhage
|
2.1%
12/567 • Number of events 18 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) Infection
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) : Other
|
3.9%
22/567 • Number of events 22 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal motility
|
2.3%
13/567 • Number of events 13 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Generalized pain
|
2.1%
12/567 • Number of events 14 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Generalized weakness/fatigue
|
3.2%
18/567 • Number of events 21 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart Failure
|
17.3%
98/567 • Number of events 138 • 12 months
|
6.1%
3/49 • Number of events 5 • 12 months
|
0.95%
1/105 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Hematologic Miscellaneous
|
7.1%
40/567 • Number of events 43 • 12 months
|
6.1%
3/49 • Number of events 3 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Hematoma: Other
|
4.2%
24/567 • Number of events 26 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Hemoptysis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Hypertension
|
1.8%
10/567 • Number of events 10 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypervolemia
|
0.18%
1/567 • Number of events 1 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Hypotension
|
2.5%
14/567 • Number of events 14 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
3.8%
4/105 • Number of events 4 • 12 months
|
|
Vascular disorders
Hypovolemia
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Infections and infestations
Infections
|
2.8%
16/567 • Number of events 16 • 12 months
|
0.00%
0/49 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Psychiatric disorders
Mental disorders
|
3.0%
17/567 • Number of events 17 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic/Endocrine disorders
|
7.4%
42/567 • Number of events 47 • 12 months
|
10.2%
5/49 • Number of events 5 • 12 months
|
1.9%
2/105 • Number of events 3 • 12 months
|
|
General disorders
Miscellaneous
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Mitral Valve
|
6.0%
34/567 • Number of events 34 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal other
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
12/567 • Number of events 12 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
General disorders
Nausea
|
1.8%
10/567 • Number of events 10 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Miscellaneous:other
|
9.7%
55/567 • Number of events 63 • 12 months
|
8.2%
4/49 • Number of events 4 • 12 months
|
5.7%
6/105 • Number of events 6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.8%
33/567 • Number of events 37 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
3.8%
4/105 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.8%
27/567 • Number of events 27 • 12 months
|
6.1%
3/49 • Number of events 3 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Pseudoaneurysm
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.9%
11/567 • Number of events 11 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.71%
4/567 • Number of events 5 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
8.3%
47/567 • Number of events 53 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
6.7%
7/105 • Number of events 7 • 12 months
|
|
Renal and urinary disorders
Renal: Other
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Renal/Urinary Infection
|
4.8%
27/567 • Number of events 30 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
5/567 • Number of events 5 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin infections
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Stroke (ischemic or hemorrhagic)
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Syncope and dizziness
|
3.7%
21/567 • Number of events 22 • 12 months
|
4.1%
2/49 • Number of events 3 • 12 months
|
0.95%
1/105 • Number of events 2 • 12 months
|
|
Nervous system disorders
Transient ischemic attack (TIA)
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Thrombosis
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Tricuspid Valve
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Urinary Miscellaneous
|
2.3%
13/567 • Number of events 15 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Vascular : other
|
3.9%
22/567 • Number of events 24 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular arrhythmias
|
4.2%
24/567 • Number of events 25 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory disorders
|
0.00%
0/567 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
MitraClip Therapy
n=567 participants at risk
Patients treated with the MitraClip System.
MitraClip: The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
|
Medical Management
n=49 participants at risk
Patients with MR managed nonsurgically based on standard hospital clinical practice.
Medical Management: The NonSurgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed nonsurgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included.
|
Mitral Valve Surgery
n=105 participants at risk
Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice. Mitral Valve Surgery: The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Septal Defect (ASD)
|
2.6%
15/567 • Number of events 16 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Arteriovenous (AV) fistula Fistula
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Atrioventricular block (AV block)
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
10.1%
57/567 • Number of events 69 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
7.6%
8/105 • Number of events 8 • 12 months
|
|
Cardiac disorders
Angina
|
2.3%
13/567 • Number of events 14 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Aortic Valve
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Arrhythmia, Other
|
4.6%
26/567 • Number of events 26 • 12 months
|
8.2%
4/49 • Number of events 5 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Cardiac disorders
Arrhythmias
|
2.3%
13/567 • Number of events 15 • 12 months
|
0.00%
0/49 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Ascites
|
1.6%
9/567 • Number of events 12 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Atrial arrhythmias
|
7.9%
45/567 • Number of events 55 • 12 months
|
10.2%
5/49 • Number of events 6 • 12 months
|
19.0%
20/105 • Number of events 25 • 12 months
|
|
Infections and infestations
Bacteremia/Septicemea
|
2.1%
12/567 • Number of events 12 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Bleeding complications
|
4.6%
26/567 • Number of events 26 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Vascular disorders
Blood pressure complications
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Bone and Joint Injuries
|
1.2%
7/567 • Number of events 9 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Breathing abnormalities
|
13.4%
76/567 • Number of events 94 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial and Lung disorders
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Bruise/Contusion/Ecchymosis
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Coronary artery disease (CAD)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
1.2%
7/567 • Number of events 8 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiac: Other
|
5.5%
31/567 • Number of events 32 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.88%
5/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Cardiomyopathy
|
2.5%
14/567 • Number of events 14 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Nervous system disorders
Cerebrovascular : Other
|
1.8%
10/567 • Number of events 10 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Circulatory collapse
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
2.9%
3/105 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Coagulopathology
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Cough (non-productive)
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Injury, poisoning and procedural complications
Device complications
|
3.2%
18/567 • Number of events 19 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Edema
|
7.9%
45/567 • Number of events 49 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Endocarditis
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Epidermal and dermal conditions
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Epistaxis
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Esophageal injury
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Eye disorders
Eye disorders
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Fever
|
2.1%
12/567 • Number of events 12 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) hemorrhage
|
2.1%
12/567 • Number of events 18 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) Infection
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal (GI) : Other
|
3.9%
22/567 • Number of events 22 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal motility
|
2.3%
13/567 • Number of events 13 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Generalized pain
|
2.1%
12/567 • Number of events 14 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Generalized weakness/fatigue
|
3.2%
18/567 • Number of events 21 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart Failure
|
17.3%
98/567 • Number of events 138 • 12 months
|
6.1%
3/49 • Number of events 5 • 12 months
|
0.95%
1/105 • Number of events 3 • 12 months
|
|
Blood and lymphatic system disorders
Hematologic Miscellaneous
|
7.1%
40/567 • Number of events 43 • 12 months
|
6.1%
3/49 • Number of events 3 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Hematoma: Other
|
4.2%
24/567 • Number of events 26 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Hemoptysis
|
0.18%
1/567 • Number of events 1 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Hypertension
|
1.8%
10/567 • Number of events 10 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Hypervolemia
|
0.18%
1/567 • Number of events 1 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Hypotension
|
2.5%
14/567 • Number of events 14 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
3.8%
4/105 • Number of events 4 • 12 months
|
|
Vascular disorders
Hypovolemia
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Infections and infestations
Infections
|
2.8%
16/567 • Number of events 16 • 12 months
|
0.00%
0/49 • 12 months
|
4.8%
5/105 • Number of events 5 • 12 months
|
|
Psychiatric disorders
Mental disorders
|
3.0%
17/567 • Number of events 17 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic/Endocrine disorders
|
7.4%
42/567 • Number of events 47 • 12 months
|
10.2%
5/49 • Number of events 5 • 12 months
|
1.9%
2/105 • Number of events 3 • 12 months
|
|
General disorders
Miscellaneous
|
1.4%
8/567 • Number of events 8 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Cardiac disorders
Mitral Valve
|
6.0%
34/567 • Number of events 34 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal other
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
12/567 • Number of events 12 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
General disorders
Nausea
|
1.8%
10/567 • Number of events 10 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Miscellaneous : other
|
9.7%
55/567 • Number of events 63 • 12 months
|
8.2%
4/49 • Number of events 4 • 12 months
|
5.7%
6/105 • Number of events 6 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.8%
33/567 • Number of events 37 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
3.8%
4/105 • Number of events 4 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.8%
27/567 • Number of events 27 • 12 months
|
6.1%
3/49 • Number of events 3 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Pseudoaneurysm
|
0.88%
5/567 • Number of events 5 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.9%
11/567 • Number of events 11 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.71%
4/567 • Number of events 5 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Renal failure
|
8.3%
47/567 • Number of events 53 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
6.7%
7/105 • Number of events 7 • 12 months
|
|
Renal and urinary disorders
Renal: Other
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Renal/Urinary Infection
|
4.8%
27/567 • Number of events 30 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.88%
5/567 • Number of events 5 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.35%
2/567 • Number of events 2 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin infections
|
0.53%
3/567 • Number of events 3 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Stroke (ischemic or hemorrhagic)
|
1.1%
6/567 • Number of events 6 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
General disorders
Syncope and dizziness
|
3.7%
21/567 • Number of events 22 • 12 months
|
4.1%
2/49 • Number of events 3 • 12 months
|
0.95%
1/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Transient ischemic attack (TIA)
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
4/567 • Number of events 4 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Vascular disorders
Thrombosis
|
1.2%
7/567 • Number of events 7 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
|
Cardiac disorders
Tricuspid Valve
|
0.53%
3/567 • Number of events 3 • 12 months
|
2.0%
1/49 • Number of events 1 • 12 months
|
0.00%
0/105 • 12 months
|
|
Renal and urinary disorders
Urinary Miscellaneous
|
2.3%
13/567 • Number of events 15 • 12 months
|
0.00%
0/49 • 12 months
|
0.00%
0/105 • 12 months
|
|
Vascular disorders
Vascular : other†
|
3.9%
22/567 • Number of events 24 • 12 months
|
0.00%
0/49 • 12 months
|
1.9%
2/105 • Number of events 2 • 12 months
|
|
Cardiac disorders
Ventricular arrhythmias
|
4.2%
24/567 • Number of events 25 • 12 months
|
4.1%
2/49 • Number of events 2 • 12 months
|
0.00%
0/105 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory disorders
|
0.00%
0/567 • 12 months
|
0.00%
0/49 • 12 months
|
0.95%
1/105 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60