Trial Outcomes & Findings for AVJ-514 Japan Trial (NCT NCT02520310)

Results Overview

APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

On day 0 (the day of procedure)

Results posted on

2021-06-11

Participant Flow

A total of 30 subjects were enrolled at 6 japan sites from September 7, 2015 to June 14, 2016.

Prior to the procedure,subjects were assessed to ensure there was no significant change in the subject's overall condition (e.g.stroke,MI,active infection,etc.) that would preclude treatment. If the subject experienced any significant change, the subject was treated\&reassessed for the clinical investigation.They were not considered registered.

Participant milestones

Participant milestones
Measure	AVJ-514 This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.
At 30 Days Clinical Follow-up STARTED	30
At 30 Days Clinical Follow-up COMPLETED	30
At 30 Days Clinical Follow-up NOT COMPLETED	0
At 6 Months Clinical Follow-up STARTED	30
At 6 Months Clinical Follow-up COMPLETED	29
At 6 Months Clinical Follow-up NOT COMPLETED	1
At 1 Year Clinical Follow-up STARTED	29
At 1 Year Clinical Follow-up COMPLETED	28
At 1 Year Clinical Follow-up NOT COMPLETED	1
At 2 Year Clinical Follow-up STARTED	28
At 2 Year Clinical Follow-up COMPLETED	28
At 2 Year Clinical Follow-up NOT COMPLETED	0
AT 3 Year Clinical Follow-up STARTED	28
AT 3 Year Clinical Follow-up COMPLETED	24
AT 3 Year Clinical Follow-up NOT COMPLETED	4
AT 4 Year Clinical Follow-up STARTED	24
AT 4 Year Clinical Follow-up COMPLETED	22
AT 4 Year Clinical Follow-up NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AVJ-514 This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.
At 6 Months Clinical Follow-up Death	1
At 1 Year Clinical Follow-up Withdrawal by Subject	1
AT 3 Year Clinical Follow-up Death	2
AT 3 Year Clinical Follow-up Withdrawal by Subject	2
AT 4 Year Clinical Follow-up Death	1
AT 4 Year Clinical Follow-up missed visit	1

Baseline Characteristics

AVJ-514 Japan Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Age, Continuous	80.4 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment Japan	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: On day 0 (the day of procedure)

Population: ITT population.

APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Acute Procedure Success (APS)	26 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Intention-to-Treat (ITT) population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Percentage of Participants With Major Adverse Events (MAE) at 30 Days Death	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAE) at 30 Days Stroke	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAE) at 30 Days Myocardial infarction	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAE) at 30 Days Renal failure	0 percentage of participants
Percentage of Participants With Major Adverse Events (MAE) at 30 Days Procedure related adverse events	0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted. This section talks about MAE at 1 year. A total of two MAES were reported through 1 year. 1 MAE for Death and 1 MAE for Renal Failure.

MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Percentage of Participants With MAE at 1 Year Death	3.3 percentage of participants
Percentage of Participants With MAE at 1 Year Stroke	0 percentage of participants
Percentage of Participants With MAE at 1 Year Myocardial infarction	0 percentage of participants
Percentage of Participants With MAE at 1 Year Renal failure	3.3 percentage of participants
Percentage of Participants With MAE at 1 Year Procedure related adverse events	0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: * Death * Stroke * Myocardial infarction * Renal failure * Non-elective cardiovascular surgery for device or procedure related adverse events

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Mitral Valve Stenosis Requiring Surgery	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Mitral Valve Stenosis Not Requiring Surgery	3 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Iatrogenic Atrial Septal Defect	0 Participants

SECONDARY outcome

Timeframe: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Percentage of Participants With Device Implant Rate 0	0 percentage of participants
Percentage of Participants With Device Implant Rate 1	30 percentage of participants
Percentage of Participants With Device Implant Rate 2	63 percentage of participants
Percentage of Participants With Device Implant Rate >=3	7 percentage of participants

SECONDARY outcome

Timeframe: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Device Procedure Time	206.4 Minutes Standard Deviation 84.06

SECONDARY outcome

Timeframe: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Total Procedure Time	284.6 Minutes Standard Deviation 90.67

SECONDARY outcome

Timeframe: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Device Time	126.6 Minutes Standard Deviation 79.57

SECONDARY outcome

Timeframe: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Fluoroscopy Duration	62.5 Minutes Standard Deviation 31.11

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

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

Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)

Outcome measures

Outcome measures
Measure	AVJ-514 n=24 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)	36.8 Hours Standard Deviation 36.31

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Length of Hospital Stay Excluding Rehabilitation Stay	14.4 Days Standard Deviation 8.53

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

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

Cumulative days of rehabilitation stay during hospitalization.

Outcome measures

Outcome measures
Measure	AVJ-514 n=5 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Length of Rehabilitation Stay	4.9 Days Standard Deviation 3.12

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Location to which subject was discharged (home or another facility).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Percentage of Participants With Discharge Status Released to home	96.7 percentage of participants
Percentage of Participants With Discharge Status Released to rehab facility or skilled nursing home	3.3 percentage of participants
Percentage of Participants With Discharge Status Returned to rehab facility or skilled nursing home	0 percentage of participants
Percentage of Participants With Discharge Status Transferred to another hospital	0 percentage of participants
Percentage of Participants With Discharge Status Subject died	0 percentage of participants
Percentage of Participants With Discharge Status Other	0 percentage of participants

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

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

If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.

Outcome measures

Outcome measures
Measure	AVJ-514 n=24 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Length of Stay (Not at Baseline Facility)	2.6 Days Standard Deviation 2.66

SECONDARY outcome

Timeframe: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Mitral Regurgitation (MR) Severity Grade MR Severity Grade 0	0 Participants
Number of Participants With Mitral Regurgitation (MR) Severity Grade MR Severity Grade 1+	0 Participants
Number of Participants With Mitral Regurgitation (MR) Severity Grade MR Severity Grade 2+	0 Participants
Number of Participants With Mitral Regurgitation (MR) Severity Grade MR Severity Grade 3+	24 Participants
Number of Participants With Mitral Regurgitation (MR) Severity Grade MR Severity Grade 4+	6 Participants

SECONDARY outcome

Timeframe: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With MR Severity Grade MR severity grade 0	0 Participants
Number of Participants With MR Severity Grade MR severity grade 1+	21 Participants
Number of Participants With MR Severity Grade MR severity grade 2+	5 Participants
Number of Participants With MR Severity Grade MR severity grade 3+	4 Participants
Number of Participants With MR Severity Grade MR severity grade 4+	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With MR Severity Grade MR severity grade 0	0 Participants
Number of Participants With MR Severity Grade MR severity grade 1+	17 Participants
Number of Participants With MR Severity Grade MR severity grade 2+	9 Participants
Number of Participants With MR Severity Grade MR severity grade 3+	4 Participants
Number of Participants With MR Severity Grade MR severity grade 4+	0 Participants

SECONDARY outcome

Timeframe: 6 months

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

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=29 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With MR Severity Grade MR severity grade 0	0 Participants
Number of Participants With MR Severity Grade MR severity grade 1+	14 Participants
Number of Participants With MR Severity Grade MR severity grade 2+	9 Participants
Number of Participants With MR Severity Grade MR severity grade 3+	6 Participants
Number of Participants With MR Severity Grade MR severity grade 4+	0 Participants

SECONDARY outcome

Timeframe: 1 year

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

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=28 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With MR Severity Grade MR severity grade 0	0 Participants
Number of Participants With MR Severity Grade MR severity grade 1+	8 Participants
Number of Participants With MR Severity Grade MR severity grade 2+	13 Participants
Number of Participants With MR Severity Grade MR severity grade 3+	7 Participants
Number of Participants With MR Severity Grade MR severity grade 4+	0 Participants

SECONDARY outcome

Timeframe: 24 months

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

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=28 Participants The AVJ-514 system: Patients receiving AVJ-514 device
MR Severity Grade MR 0	0 Participants
MR Severity Grade MR 1+	12 Participants
MR Severity Grade MR 2 +	13 Participants
MR Severity Grade MR 3+	2 Participants
MR Severity Grade MR 4+	1 Participants

SECONDARY outcome

Timeframe: 3 years

Population: All subjects woth availble data

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=24 Participants The AVJ-514 system: Patients receiving AVJ-514 device
MR Severity Grade MR 0+	0 Participants
MR Severity Grade MR 1+	10 Participants
MR Severity Grade MR 2+	10 Participants
MR Severity Grade MR 3+	4 Participants
MR Severity Grade MR 4 +	0 Participants

SECONDARY outcome

Timeframe: 4 years

Population: All available data is reported

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Outcome measures

Outcome measures
Measure	AVJ-514 n=22 Participants The AVJ-514 system: Patients receiving AVJ-514 device
MR Severity Grade MR 0+	0 Participants
MR Severity Grade MR 1+	7 Participants
MR Severity Grade MR 2+	9 Participants
MR Severity Grade MR 3+	5 Participants
MR Severity Grade MR 4+	0 Participants
MR Severity Grade Not Available	1 Participants

SECONDARY outcome

Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

Outcome measures

Outcome measures
Measure	AVJ-514 n=10 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Regurgitant Volume (RV)	44.0 ml/beat Standard Deviation 22.6

SECONDARY outcome

Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Left Ventricular End Diastolic Volume (LVEDV)	138.9 ml Standard Deviation 63.6

SECONDARY outcome

Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Left Ventricular End Systolic Volume (LVESV)	83.7 ml Standard Deviation 57.3

SECONDARY outcome

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Left Ventricular End Diastolic Dimension (LVEDD)	5.7 cm Standard Deviation 0.9

SECONDARY outcome

Left Ventricular End Systolic Dimension (LVESD) as measured by the site.

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Left Ventricular End Systolic Dimension (LVESD)	4.4 cm Standard Deviation 1.2

SECONDARY outcome

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Left Ventricular Ejection Fraction (LVEF)	44.5 percentage of Ejection Fraction Standard Deviation 17.8

SECONDARY outcome

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Mean Mitral Valve Pressure Gradient (MVG)	3.6 mmHg Standard Deviation 1.3

SECONDARY outcome

Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.

Outcome measures

Outcome measures
Measure	AVJ-514 n=22 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Yes	0 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) No	21 Participants
Systolic Anterior Motion of the Mitral Valve (Present or Absent) Not Evaluable	1 Participants

SECONDARY outcome

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Outcome measures

Outcome measures
Measure	AVJ-514 n=25 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Forward Stroke Volume (FSV)	49.6 ml Standard Deviation 13.8

Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Cardiac Output (CO)	6.3 L/min Standard Deviation 9.3

SECONDARY outcome

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.

Outcome measures

Outcome measures
Measure	AVJ-514 n=19 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Cardiac Index (CI)	4.1 L/min/m^2 Standard Deviation 5.5

SECONDARY outcome

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
All-cause Mortality	5 Participants

MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Freedom From the Components of the Primary Safety Composite of MAE Death	1 Participants
Freedom From the Components of the Primary Safety Composite of MAE Stroke	1 Participants
Freedom From the Components of the Primary Safety Composite of MAE Myocardial Infarction	0 Participants
Freedom From the Components of the Primary Safety Composite of MAE Renal Failure	1 Participants
Freedom From the Components of the Primary Safety Composite of MAE Non-Elective Cardiovascular Sugery	0 Participants

SECONDARY outcome

Timeframe: 3 years

MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Freedom From the Components of the Primary Safety Composite of MAE Death	3 Participants
Freedom From the Components of the Primary Safety Composite of MAE Stroke	1 Participants
Freedom From the Components of the Primary Safety Composite of MAE Myocardial Infarction	0 Participants
Freedom From the Components of the Primary Safety Composite of MAE Renal Failure	2 Participants
Freedom From the Components of the Primary Safety Composite of MAE Non-elective cardiovascular surgery	0 Participants

SECONDARY outcome

Timeframe: 4 years

Population: This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.

MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Freedom From the Components of the Primary Safety Composite of MAE Death	5 Participants
Freedom From the Components of the Primary Safety Composite of MAE Stroke	1 Participants
Freedom From the Components of the Primary Safety Composite of MAE Myocardial Infarction	0 Participants
Freedom From the Components of the Primary Safety Composite of MAE Renal Failure	2 Participants
Freedom From the Components of the Primary Safety Composite of MAE Non-elective Cardiovascular Surgery for device or procedure related Adverse Event	0 Participants

SECONDARY outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	AVJ-514 n=27 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Change in SF-36 QoL Scores From Baseline to 1 Year Physical Component Summary	3.7 units on a scale Standard Deviation 12.5
Change in SF-36 QoL Scores From Baseline to 1 Year Mental Component Summary	1.4 units on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: 24 months

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

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Outcome measures

Outcome measures
Measure	AVJ-514 n=26 Participants The AVJ-514 system: Patients receiving AVJ-514 device
SF-36 QoL Scores Physical Function (PF)	34.5 score on a scale Standard Deviation 15.8
SF-36 QoL Scores Role Physical (RP)	39.5 score on a scale Standard Deviation 12.7
SF-36 QoL Scores Bodily Pain (BP)	48.8 score on a scale Standard Deviation 12.7
SF-36 QoL Scores General Health (GH)	45.3 score on a scale Standard Deviation 8.8

SECONDARY outcome

Timeframe: At 24 months

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

Outcome measures

Outcome measures
Measure	AVJ-514 n=26 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Change in SF-36 QoL Scores From Baseline Physical Function (PF)	0.7 score on a scale Standard Deviation 12.4
Change in SF-36 QoL Scores From Baseline Role Physical (RP)	4.7 score on a scale Standard Deviation 14.5
Change in SF-36 QoL Scores From Baseline Bodily Pain (BP)	0.7 score on a scale Standard Deviation 13.3
Change in SF-36 QoL Scores From Baseline General Health (GH)	2.0 score on a scale Standard Deviation 8.7

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

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Outcome measures
Measure	AVJ-514 n=28 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Six Minute Walk Test (6MWT) Distance	338.6 meters Standard Deviation 106.5

SECONDARY outcome

Timeframe: 1 year

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

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Outcome measures
Measure	AVJ-514 n=28 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Six Minute Walk Test (6MWT) Distance	359.0 meters Standard Deviation 111.3

SECONDARY outcome

Timeframe: Baseline to 1 year

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

Outcome measures

Outcome measures
Measure	AVJ-514 n=28 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year	1.4 meters Standard Deviation 79.1

SECONDARY outcome

Timeframe: 24 months

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

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Outcome measures
Measure	AVJ-514 n=25 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Six Minute Walk Test (6MWT) Distance	313.7 meters Standard Deviation 136.7

SECONDARY outcome

Timeframe: At 24 months

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

Outcome measures

Outcome measures
Measure	AVJ-514 n=25 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Changes in Six Minute Walk Test (6MWT) Distance From Baseline	-40.8 meters Standard Deviation 86.9

SECONDARY outcome

Timeframe: 3 years

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

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Outcome measures
Measure	AVJ-514 n=21 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Six Minute Walk Test (6MWT) Distance	336.8 meters Standard Deviation 119.4

SECONDARY outcome

Timeframe: 4 years

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

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Outcome measures

Outcome measures
Measure	AVJ-514 n=16 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Six Minute Walk Test (6MWT) Distance	324.3 Meters Standard Deviation 112.7

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	AVJ-514 n=10 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Hospitalizations and Reason for Hospitalization Heart failure	4 Participants
Number of Hospitalizations and Reason for Hospitalization Cardiovascular	2 Participants
Number of Hospitalizations and Reason for Hospitalization Non-cardiovascular	9 Participants

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Mitral Stenosis	3 Participants

SECONDARY outcome

Timeframe: 3 years

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Mitral Stenosis	3 Participants

SECONDARY outcome

Timeframe: 4 years

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Mitral Stenosis	3 Participants

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior 1 year pre index procedure	0.90 Rate of HF Hospitalization Interval 0.62 to 1.31
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior 1 year post index procedure	0.14 Rate of HF Hospitalization Interval 0.05 to 0.37

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Device Embolization Requiring Surgery	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.

Outcome measures

Outcome measures
Measure	AVJ-514 n=30 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Number of Participants With Device Embolization Not Requiring Surgery	0 Participants

SECONDARY outcome

Timeframe: 2 year

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

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Outcome measures

Outcome measures
Measure	AVJ-514 n=15 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Regurgitant Fraction (RF)	28.6 percentage of regurgitant fraction Standard Deviation 15.0

SECONDARY outcome

Timeframe: 3 year

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

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Outcome measures

Outcome measures
Measure	AVJ-514 n=15 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Regurgitant Fraction (RF)	29.8 percentage of regurgitant fraction Standard Deviation 18.5

SECONDARY outcome

Timeframe: 4 year

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

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Outcome measures

Outcome measures
Measure	AVJ-514 n=10 Participants The AVJ-514 system: Patients receiving AVJ-514 device
Regurgitant Fraction (RF)	44.7 percentage of regurgitant fraction Standard Deviation 22.9

Adverse Events

AVJ-514

Serious events: 27 serious events

Other events: 30 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	AVJ-514 n=30 participants at risk AVJ-514: Patients receiving AVJ-514 device
Cardiac disorders Atrial fibrillation	10.0% 3/30 • Number of events 3 • 4 year
Cardiac disorders Cardiac Failure Chronic	6.7% 2/30 • Number of events 4 • 4 year
Cardiac disorders Cardiac failure	26.7% 8/30 • Number of events 14 • 4 year
Cardiac disorders Atrial thrombus	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Ventricular tachycardia	3.3% 1/30 • Number of events 1 • 4 year
Eye disorders Cataract	13.3% 4/30 • Number of events 5 • 4 year
Cardiac disorders Cardiac Failure Congestive	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Sick Sinus Syndrome	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Pneumonia	10.0% 3/30 • Number of events 4 • 4 year
Infections and infestations Bronchitis	6.7% 2/30 • Number of events 2 • 4 year
Infections and infestations Bronchopneumonia	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Cellulitis	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Herpes Zoster	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Implant Site Infection	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Infection	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Influenza	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Sepsis	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Urinary Tract Infection	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Dementia Alzheimer's Type	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Ischaemic Stroke	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Senile Dementia	3.3% 1/30 • Number of events 1 • 4 year
General disorders Adverse Drug Reaction	3.3% 1/30 • Number of events 1 • 4 year
General disorders Chest Discomfort	3.3% 1/30 • Number of events 1 • 4 year
General disorders Oedema Peripheral	3.3% 1/30 • Number of events 1 • 4 year
General disorders Pyrexia	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Acetabulum Fracture	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Spinal Compression Fracture	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Subdural Haematoma	3.3% 1/30 • Number of events 1 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	6.7% 2/30 • Number of events 2 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	3.3% 1/30 • Number of events 1 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Intestine Carcinoma	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Muscle Atrophy	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Renal Failure	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Urethral Stenosis	3.3% 1/30 • Number of events 1 • 4 year
Blood and lymphatic system disorders Anaemia	3.3% 1/30 • Number of events 1 • 4 year
Ear and labyrinth disorders Sudden Hearing Loss	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	10.0% 3/30 • Number of events 3 • 4 year
Surgical and medical procedures Tooth Extraction	3.3% 1/30 • Number of events 1 • 4 year
Vascular disorders Hypotension	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Haematuria	3.3% 1/30 • Number of events 1 • 4 year
Surgical and medical procedures Polypectomy	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Gastrointestinal haemorrhage	3.3% 1/30 • Number of events 1 • 4 year
Hepatobiliary disorders Cholelithiasis	3.3% 1/30 • Number of events 1 • 4 year

Other adverse events

Other adverse events
Measure	AVJ-514 n=30 participants at risk AVJ-514: Patients receiving AVJ-514 device
Blood and lymphatic system disorders Anaemia	16.7% 5/30 • Number of events 7 • 4 year
Blood and lymphatic system disorders Nephrogenic anaemia	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Angina pectoris	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Atrial fibrillation	6.7% 2/30 • Number of events 2 • 4 year
Cardiac disorders Atrial thrombosis	6.7% 2/30 • Number of events 2 • 4 year
Cardiac disorders Cardiac failure	10.0% 3/30 • Number of events 3 • 4 year
Cardiac disorders Cardiac failure chronic	6.7% 2/30 • Number of events 2 • 4 year
Cardiac disorders Left ventricular dysfunction	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Mitral valve incompetence	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Pericardial effusion	6.7% 2/30 • Number of events 2 • 4 year
Cardiac disorders Atrial Tachycardia	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Tricuspid valve incompetence	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Ventricular extrasystoles	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Ventricular tachycardia	3.3% 1/30 • Number of events 1 • 4 year
Endocrine disorders Hypothyroidism	3.3% 1/30 • Number of events 1 • 4 year
Eye disorders Angle closure glaucoma	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Abdominal pain lower	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Constipation	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Dysphagia	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Enteritis	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Haemorrhoids	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Inguinal hernia	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Mouth haemorrhage	3.3% 1/30 • Number of events 1 • 4 year
Gastrointestinal disorders Varices oesophageal	3.3% 1/30 • Number of events 1 • 4 year
General disorders Adverse drug reaction	10.0% 3/30 • Number of events 3 • 4 year
General disorders Catheter site haematoma	6.7% 2/30 • Number of events 2 • 4 year
General disorders Catheter site haemorrhage	23.3% 7/30 • Number of events 8 • 4 year
General disorders Catheter site pain	10.0% 3/30 • Number of events 3 • 4 year
General disorders Device lead issue	3.3% 1/30 • Number of events 1 • 4 year
General disorders Inflammation	3.3% 1/30 • Number of events 1 • 4 year
General disorders Non-cardiac chest pain	3.3% 1/30 • Number of events 2 • 4 year
General disorders Oedema peripheral	3.3% 1/30 • Number of events 1 • 4 year
General disorders Pyrexia	6.7% 2/30 • Number of events 2 • 4 year
Infections and infestations Bronchitis	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Infection	3.3% 1/30 • Number of events 2 • 4 year
Infections and infestations Sepsis	3.3% 1/30 • Number of events 2 • 4 year
Infections and infestations Herpes zoster	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Influenza	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Nasopharyngitis	10.0% 3/30 • Number of events 4 • 4 year
Infections and infestations Oesophageal infection	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Pneumonia	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Tinea infection	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Urinary tract infection	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Contusion	13.3% 4/30 • Number of events 4 • 4 year
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Drug administration error	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Fall	10.0% 3/30 • Number of events 3 • 4 year
Injury, poisoning and procedural complications Head injury	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Joint dislocation	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Ligament sprain	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Post procedural haemorrhage	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Postoperative fever	6.7% 2/30 • Number of events 2 • 4 year
Injury, poisoning and procedural complications Procedural complication	6.7% 2/30 • Number of events 3 • 4 year
Injury, poisoning and procedural complications Procedural headache	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Procedural nausea	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Procedural pain	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Rib fracture	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Spinal compression fracture	6.7% 2/30 • Number of events 2 • 4 year
Injury, poisoning and procedural complications Subdural haematoma	3.3% 1/30 • Number of events 2 • 4 year
Investigations Blood creatine phosphokinase mb increased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Blood creatinine increased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Blood urine present	3.3% 1/30 • Number of events 1 • 4 year
Investigations Brain natriuretic peptide increased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Cardiac enzymes increased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Echocardiogram abnormal	3.3% 1/30 • Number of events 1 • 4 year
Investigations Ejection fraction decreased	10.0% 3/30 • Number of events 3 • 4 year
Investigations Helicobacter test positive	3.3% 1/30 • Number of events 1 • 4 year
Investigations Hepatic enzyme increased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Inflammatory marker increased	6.7% 2/30 • Number of events 2 • 4 year
Investigations Platelet count decreased	3.3% 1/30 • Number of events 1 • 4 year
Investigations Urine viscosity abnormal	3.3% 1/30 • Number of events 1 • 4 year
Investigations White blood cell count increased	6.7% 2/30 • Number of events 2 • 4 year
Metabolism and nutrition disorders Decreased appetite	3.3% 1/30 • Number of events 1 • 4 year
Metabolism and nutrition disorders Hyperuricaemia	3.3% 1/30 • Number of events 1 • 4 year
Metabolism and nutrition disorders Hypoalbuminaemia	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Back pain	6.7% 2/30 • Number of events 2 • 4 year
Musculoskeletal and connective tissue disorders Limb discomfort	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Muscle spasms	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 2/30 • Number of events 2 • 4 year
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 2/30 • Number of events 2 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Balance disorder	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Dysgeusia	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Hypoaesthesia	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Sedation	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Somnolence	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Haematuria	6.7% 2/30 • Number of events 2 • 4 year
Renal and urinary disorders Renal failure	6.7% 2/30 • Number of events 2 • 4 year
Renal and urinary disorders Renal impairment	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Urethral pain	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Urethral stenosis	3.3% 1/30 • Number of events 1 • 4 year
Renal and urinary disorders Urinary retention	3.3% 1/30 • Number of events 1 • 4 year
Reproductive system and breast disorders Genital erythema	3.3% 1/30 • Number of events 1 • 4 year
Reproductive system and breast disorders Haematospermia	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Cough	6.7% 2/30 • Number of events 2 • 4 year
Respiratory, thoracic and mediastinal disorders Dysphonia	6.7% 2/30 • Number of events 2 • 4 year
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • 4 year
Respiratory, thoracic and mediastinal disorders Productive cough	10.0% 3/30 • Number of events 3 • 4 year
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	3.3% 1/30 • Number of events 1 • 4 year
Respiratory, thoracic and mediastinal disorders Sputum increased	3.3% 1/30 • Number of events 1 • 4 year
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	3.3% 1/30 • Number of events 1 • 4 year
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Number of events 1 • 4 year
Skin and subcutaneous tissue disorders Rash	3.3% 1/30 • Number of events 1 • 4 year
Skin and subcutaneous tissue disorders Xeroderma	3.3% 1/30 • Number of events 1 • 4 year
Vascular disorders Haematoma	6.7% 2/30 • Number of events 2 • 4 year
Vascular disorders Haemorrhage	6.7% 2/30 • Number of events 2 • 4 year
Vascular disorders Hypertension	3.3% 1/30 • Number of events 1 • 4 year
Vascular disorders Hypotension	3.3% 1/30 • Number of events 1 • 4 year
General disorders Chest Discomfort	3.3% 1/30 • Number of events 1 • 4 year
Infections and infestations Implant Site Infection	3.3% 1/30 • Number of events 1 • 4 year
Injury, poisoning and procedural complications Acetabulum Fracture	3.3% 1/30 • Number of events 1 • 4 year
Musculoskeletal and connective tissue disorders Muscle Atrophy	3.3% 1/30 • Number of events 1 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	3.3% 1/30 • Number of events 1 • 4 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Intestine Carcinoma	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Dementia Alzheimer's Type	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Ischaemia Stroke	3.3% 1/30 • Number of events 1 • 4 year
Nervous system disorders Senile Dementia	3.3% 1/30 • Number of events 1 • 4 year
Ear and labyrinth disorders Sudden Hearing Loss	3.3% 1/30 • Number of events 1 • 4 year
Surgical and medical procedures Tooth Extraction	3.3% 1/30 • Number of events 1 • 4 year
Cardiac disorders Tachycardia	3.3% 1/30 • Number of events 1 • 4 year

Additional Information

Sripad Bellary

Abbott Structural Heart

Phone: 650-353-1726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place