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REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System (REPAIR)

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ClinicalTrials.gov Identifier: NCT02703311
Recruitment Status : Terminated (Edwards acquired Valtech Cardio Ltd in 2017 and opted to replace this study with NCT03600688.11 patients were enrolled in REPAIR and follow-up is complete.)
First Posted : March 9, 2016
Results First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mitral Valve Insufficiency
Cardiac Valve Annuloplasty
Mitral Valve Annuloplasty
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Mitral Regurgitation
Intervention Device: Cardioband
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cardioband
Hide Arm/Group Description Patients who were enrolled and had the Cardioband procedure attempted
Period Title: Overall Study
Started 11
Implanted 11
30 Day Follow-Up Completed 9
Completed [1] 3
Not Completed 8
Reason Not Completed
Death             5
Withdrawal by Subject             3
[1]
Completed Study (2 years)
Arm/Group Title Cardioband
Hide Arm/Group Description Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
73.9  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
5
  45.5%
Male
6
  54.5%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
EuroScore II   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
7.1  (5.3)
[1]
Measure Description:

The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a risk model which allows the calculation of the risk of death after a heart operation.

EuroScore II risk levels are as follows:

Low risk: <8

Moderate risk: 8-10

High risk: >10

NYHA Functional Class III or IV   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
11
 100.0%
[1]
Measure Description:

NYHA Classification - The stages of heart failure:

Class I - No symptoms and no limitation in ordinary physical activity.

Class II - Mild symptoms and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest.

Ischemic Etiology of Regurgitation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
4
  36.4%
Dilated Cardiomyopathy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
5
  45.5%
Previous Coronary Artery Bypass Graft  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
4
  36.4%
Chronic Renal Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
8
  72.7%
Paroxysmal, Persistent, Chronic Atrial Flutter/Fibrillation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
10
  90.9%
1.Primary Outcome
Title Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Hide Description Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intra-subject comparison of patients with paired data at baseline and 30 days
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
4
  57.1%
2.Secondary Outcome
Title Change in Distance Walked on 6 Minute Walk Test
Hide Description Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Time Frame 6 months over Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intra-subject comparison of patients with paired data at baseline and 6 months
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 6
Median (Standard Deviation)
Unit of Measure: Meters
30.7  (60.4)
3.Secondary Outcome
Title Change in Mitral Regurgitation Severity
Hide Description Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Time Frame 6, 12, and 24 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 9 participants
None/Trace
0
   0.0%
Mild
2
  22.2%
Moderate
4
  44.4%
Severe
3
  33.3%
6 Months Number Analyzed 5 participants
None/Trace
1
  20.0%
Mild
3
  60.0%
Moderate
1
  20.0%
Severe
0
   0.0%
12 Months Number Analyzed 3 participants
None/Trace
0
   0.0%
Mild
3
 100.0%
Moderate
0
   0.0%
Severe
0
   0.0%
24 Months Number Analyzed 0 participants
None/Trace
Mild
Moderate
Severe
4.Other Pre-specified Outcome
Title Change in Distance Walked on 6 Minute Walk Test
Hide Description Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
Time Frame 12, and 24 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description 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.
Time Frame 6, 12, and 24 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Change in New York Heart Association (NYHA) Class
Hide Description NYHA Class at 6, 12, and 24 months compared to baseline
Time Frame 6, 12, and 24 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Change in Left Ventricular End Diastolic Volume (LVEDV)
Hide Description Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame 6, 12, and 24 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Change in Left Ventricular End Systolic Volume (LVESV)
Hide Description Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame 6, 12, and 24 months over baselines
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Number of Participants With Device Success
Hide Description Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
Time Frame Discharge
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
7
  87.5%
10.Other Pre-specified Outcome
Title Number of Participants With Patient Success
Hide Description

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
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
6 Months Number Analyzed 5 participants
3
  60.0%
12 Months Number Analyzed 4 participants
3
  75.0%
11.Other Pre-specified Outcome
Title Number of Days Alive and Out of Hospital
Hide Description Days alive and out of hospital due to major cardiovascular events at 1 year
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Freedom From All-cause Mortality and Major Adverse Events (AE)
Hide Description 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.
Time Frame 30 days from implant procedure or hospital discharge, whichever is later.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
10
  90.9%
13.Other Pre-specified Outcome
Title Need for Urgent/Emergent Surgical Intervention
Hide Description Number of patients who undergo urgent/emergent surgical intervention post procedure
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cardioband
Hide Arm/Group Description:
Patients who were enrolled and had the Cardioband procedure attempted
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cardioband
Hide Arm/Group Description Patients who were enrolled and had the Cardioband procedure attempted
All-Cause Mortality
Cardioband
Affected / at Risk (%)
Total   5/11 (45.45%)    
Hide Serious Adverse Events
Cardioband
Affected / at Risk (%) # Events
Total   9/11 (81.82%)    
Cardiac disorders   
Arrhythmia   1/11 (9.09%)  1
Atrial Fibrillation  [1]  1/11 (9.09%)  1
Cardiac Failure   6/11 (54.55%)  11
Cardiac Failure Acute   1/11 (9.09%)  1
Ventricular Tachycardia   2/11 (18.18%)  2
Ear and labyrinth disorders   
Vertigo   1/11 (9.09%)  1
Gastrointestinal disorders   
Enteritis   1/11 (9.09%)  1
Large Intestine Polyp   1/11 (9.09%)  1
Mechanical Ileus   1/11 (9.09%)  1
General disorders   
General Physical Health Deterioration   1/11 (9.09%)  1
Infections and infestations   
Bacterial Infection   1/11 (9.09%)  1
Dermohypodermitis   1/11 (9.09%)  1
Gastroenteritis   1/11 (9.09%)  1
Pneumonia   2/11 (18.18%)  2
Metabolism and nutrition disorders   
Metabolic Disorder   1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute Myeloid Leukaemia   1/11 (9.09%)  1
Nervous system disorders   
IIIrd Nerve Disorder   1/11 (9.09%)  1
Product Issues   
Device Malfunction   1/11 (9.09%)  1
Psychiatric disorders   
Completed Suicide   1/11 (9.09%)  1
Renal and urinary disorders   
Haemorrhage Urinary Tract   1/11 (9.09%)  1
Oliguria   1/11 (9.09%)  1
Renal Failure   1/11 (9.09%)  1
Urinary Retention   1/11 (9.09%)  1
Reproductive system and breast disorders   
Cervix Oedema   1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/11 (9.09%)  1
Vascular disorders   
Circulatory Collapse   1/11 (9.09%)  1
Embolism   1/11 (9.09%)  1
Hypotension   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
One patient experienced two Atrial Fibrillation adverse events (one serious and one non-serious). Both episodes are reported for this patient, one under Serious Adverse Events and the other under Other (Not Including Serious) Adverse Events.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cardioband
Affected / at Risk (%) # Events
Total   9/11 (81.82%)    
Blood and lymphatic system disorders   
Anaemia   1/11 (9.09%)  1
Heparin Induced Thrombocytopenia   1/11 (9.09%)  1
Iron Deficiency Anaemia   1/11 (9.09%)  1
Leukocytosis   1/11 (9.09%)  1
Hypochromic Anaemia   1/11 (9.09%)  1
Cardiac disorders   
Atrial Fibrillation  [1]  2/11 (18.18%)  2
Supraventricular Tachycardia   1/11 (9.09%)  1
Endocrine disorders   
Hyperthyroidism   2/11 (18.18%)  2
Gastrointestinal disorders   
Abdominal Pain Upper   1/11 (9.09%)  1
Diarrhoea   2/11 (18.18%)  2
Haemorrhoids   1/11 (9.09%)  1
General disorders   
Pyrexia   1/11 (9.09%)  1
Infections and infestations   
Nasopharyngitis   1/11 (9.09%)  1
Puncture Site Infection   1/11 (9.09%)  1
Sepsis   1/11 (9.09%)  1
Tooth Infection   1/11 (9.09%)  1
Urinary Tract Infection   4/11 (36.36%)  4
Viral Upper Respiratory Tract Infection   1/11 (9.09%)  1
Injury, poisoning and procedural complications   
Contusion   1/11 (9.09%)  1
Fall   2/11 (18.18%)  2
Investigations   
Creactive Protein Increased   1/11 (9.09%)  1
Haemoglobin Decreased   2/11 (18.18%)  2
Weight Increased   1/11 (9.09%)  1
Metabolism and nutrition disorders   
Gout   1/11 (9.09%)  1
Hypokalaemia   1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Joint Swelling   1/11 (9.09%)  1
Musculoskeletal Pain   1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Renal Cell Carcinoma   1/11 (9.09%)  1
Nervous system disorders   
Depressed Level of Conciousness   1/11 (9.09%)  1
Product Issues   
Device Pacing Issue   1/11 (9.09%)  1
Psychiatric disorders   
Depression   1/11 (9.09%)  1
Renal and urinary disorders   
Renal Failure   3/11 (27.27%)  3
Respiratory, thoracic and mediastinal disorders   
Epistaxis   1/11 (9.09%)  1
Obstructive Airways Disorder   1/11 (9.09%)  1
Pleural Effusion   3/11 (27.27%)  3
Skin and subcutaneous tissue disorders   
Pruritus   1/11 (9.09%)  1
Vascular disorders   
Hypotension   1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
One patient experienced two Atrial Fibrillation adverse events (one serious and one non-serious). Both episodes are reported for this patient, one under Serious Adverse Events and the other under Other (Not Including Serious) Adverse Events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ted Feldman
Organization: Edwards Lifesciences
Phone: 949-250-2500
EMail: Feldman_Info@edwards.com
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02703311    
Other Study ID Numbers: CB1-3
First Submitted: February 22, 2016
First Posted: March 9, 2016
Results First Submitted: September 3, 2020
Results First Posted: November 9, 2020
Last Update Posted: November 9, 2020