Trial Outcomes & Findings for REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System (NCT NCT02703311)
NCT ID: NCT02703311
Last Updated: 2020-11-09
Results Overview
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
TERMINATED
NA
11 participants
30 days
2020-11-09
Participant Flow
Participant milestones
| Measure |
Cardioband
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
Implanted
|
11
|
|
Overall Study
30 Day Follow-Up Completed
|
9
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Cardioband
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cardioband
n=11 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 9.0 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
|
EuroScore II
|
7.1 units on a scale
STANDARD_DEVIATION 5.3 • n=11 Participants
|
|
NYHA Functional Class III or IV
|
11 Participants
n=11 Participants
|
|
Ischemic Etiology of Regurgitation
|
4 Participants
n=11 Participants
|
|
Dilated Cardiomyopathy
|
5 Participants
n=11 Participants
|
|
Previous Coronary Artery Bypass Graft
|
4 Participants
n=11 Participants
|
|
Chronic Renal Disease
|
8 Participants
n=11 Participants
|
|
Paroxysmal, Persistent, Chronic Atrial Flutter/Fibrillation
|
10 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Intra-subject comparison of patients with paired data at baseline and 30 days
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Outcome measures
| Measure |
Cardioband
n=7 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months over BaselinePopulation: Intra-subject comparison of patients with paired data at baseline and 6 months
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Outcome measures
| Measure |
Cardioband
n=6 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Change in Distance Walked on 6 Minute Walk Test
|
30.7 Meters
Standard Deviation 60.4
|
SECONDARY outcome
Timeframe: 6, 12, and 24 months over baselinePopulation: This planned endpoint of change mitral regurgitation severity in was unable to be analyzed due to the small sample size that was achieved in this study. Data available at each time point were reported as number of patients with MR grades None/Trace, Mild, Moderate, Severe.
Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Outcome measures
| Measure |
Cardioband
n=9 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Change in Mitral Regurgitation Severity
Baseline · None/Trace
|
0 Participants
|
|
Change in Mitral Regurgitation Severity
Baseline · Mild
|
2 Participants
|
|
Change in Mitral Regurgitation Severity
Baseline · Moderate
|
4 Participants
|
|
Change in Mitral Regurgitation Severity
Baseline · Severe
|
3 Participants
|
|
Change in Mitral Regurgitation Severity
6 Months · None/Trace
|
1 Participants
|
|
Change in Mitral Regurgitation Severity
6 Months · Mild
|
3 Participants
|
|
Change in Mitral Regurgitation Severity
6 Months · Moderate
|
1 Participants
|
|
Change in Mitral Regurgitation Severity
6 Months · Severe
|
0 Participants
|
|
Change in Mitral Regurgitation Severity
12 Months · None/Trace
|
0 Participants
|
|
Change in Mitral Regurgitation Severity
12 Months · Mild
|
3 Participants
|
|
Change in Mitral Regurgitation Severity
12 Months · Moderate
|
0 Participants
|
|
Change in Mitral Regurgitation Severity
12 Months · Severe
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12, and 24 months over baselinePopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 months over baselinePopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Median KCCQ Score. The KCCQ 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. Scores range from 0-100, in which higher scores reflect better health status.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 months over baselinePopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
NYHA Class at 6, 12, and 24 months compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 months over baselinePopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6, 12, and 24 months over baselinesPopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: DischargePopulation: The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
Outcome measures
| Measure |
Cardioband
n=8 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Number of Participants With Device Success
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsPopulation: The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
Individual patient success (measured at 6 months and 1 year) defined as device success and the following: * Discharged from index hospitalization * NYHA class improvement by at least 1 level from baseline
Outcome measures
| Measure |
Cardioband
n=5 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Number of Participants With Patient Success
6 Months
|
3 Participants
|
|
Number of Participants With Patient Success
12 Months
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Days alive and out of hospital due to major cardiovascular events at 1 year
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days from implant procedure or hospital discharge, whichever is later.Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
Outcome measures
| Measure |
Cardioband
n=11 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Freedom From All-cause Mortality and Major Adverse Events (AE)
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsNumber of patients who undergo urgent/emergent surgical intervention post procedure
Outcome measures
| Measure |
Cardioband
n=11 Participants
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Need for Urgent/Emergent Surgical Intervention
|
0 Participants
|
Adverse Events
Cardioband
Serious adverse events
| Measure |
Cardioband
n=11 participants at risk
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Cardiac disorders
Cardiac Failure
|
54.5%
6/11 • Number of events 11 • 2 years
|
|
Cardiac disorders
Cardiac Failure Acute
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Cardiac disorders
Ventricular Tachycardia
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Enteritis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mechanical Ileus
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
General disorders
General Physical Health Deterioration
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Bacterial Infection
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Dermohypodermitis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Gastroenteritis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Nervous system disorders
IIIrd Nerve Disorder
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Product Issues
Device Malfunction
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Completed Suicide
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Oliguria
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal Failure
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Cervix Oedema
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Vascular disorders
Circulatory Collapse
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Vascular disorders
Embolism
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
9.1%
1/11 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Cardioband
n=11 participants at risk
Patients who were enrolled and had the Cardioband procedure attempted
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Heparin Induced Thrombocytopenia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Cardiac disorders
Supraventricular Tachycardia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Investigations
Creactive Protein Increased
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Investigations
Haemoglobin Decreased
|
18.2%
2/11 • Number of events 2 • 2 years
|
|
Investigations
Weight Increased
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Gout
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Puncture Site Infection
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Tooth Infection
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
36.4%
4/11 • Number of events 4 • 2 years
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Nervous system disorders
Depressed Level of Conciousness
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Product Issues
Device Pacing Issue
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal Failure
|
27.3%
3/11 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
27.3%
3/11 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
9.1%
1/11 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place