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

The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.

Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Regurgitation; Mitral Valve Insufficiency; Cardiac Valve Annuloplasty; Mitral Valve Annuloplasty
• Intervention / Treatment: Device: Cardioband

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 18 75877
    • Bichat Hospital
• Germany
  • Bad Nauheim, Germany, 61231
    • Bad Nauheim, Kerckhoff-Klinik
  • Bonn, Germany
    • Bonn University
  • Giessen, Germany
    • Universitätsklinikum Gießen und Marburg
  • Halle, Germany
    • University Hospital Halle (Saale)
  • Hamburg, Germany, 5 20099
    • Asklepios Klinik, St. Georg
  • Hamburg, Germany
    • Universitäres Herzzentrum Hamburg GmbH
  • Koln, Germany
    • Koln, Universitätsklinikum
  • Mainz, Germany
    • Universitätsmedizin Mainz
• Italy
  • Milano, Italy, 20132
    • Hospital San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years
2. Severe (3+ to 4+) secondary Mitral Regurgitation
3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
6. Subject is willing and able to provide informed consent and follow protocol

Exclusion Criteria:

1. EF < 20%
2. LVEDD ≥ 70 mm
3. Heavily calcified annulus or leaflets
4. Significant CAD requiring revascularization
5. Active bacterial endocarditis
6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
7. Renal insufficiency requiring dialysis
8. Life expectancy of less than twelve months
9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
10. Pulmonary hypertension ≥ 70mmHg at rest
11. Mitral valve anatomy which may preclude proper device treatment
12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
13. Severe liver disease
14. Patient is pregnant or lactating
15. Hypersensitivity to Nickel or Chromium
16. Clinically significant bleeding diathesis or coagulopathy
17. History of mitral valve repair
18. TIA or CVA within 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cardioband procedure; Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance	Device: Cardioband; Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.	Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Distance Walked on 6 Minute Walk Test	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline	6 months over Baseline
Change in Mitral Regurgitation Severity	Mitral Regurgitation at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Distance Walked on 6 Minute Walk Test	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline	12, and 24 months over baseline
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	6, 12, and 24 months over baseline
Change in New York Heart Association (NYHA) Class	NYHA Class at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline
Change in Left Ventricular End Diastolic Volume (LVEDV)	Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baseline
Change in Left Ventricular End Systolic Volume (LVESV)	Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline	6, 12, and 24 months over baselines
Number of Participants With Device Success	Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.	Discharge
Number of Participants With Patient Success	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	6 and 12 months
Number of Days Alive and Out of Hospital	Days alive and out of hospital due to major cardiovascular events at 1 year	12 months
Freedom From All-cause Mortality and Major Adverse Events (AE)	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.	30 days from implant procedure or hospital discharge, whichever is later.
Need for Urgent/Emergent Surgical Intervention	Number of patients who undergo urgent/emergent surgical intervention post procedure	24 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Mitral Valve; Valtech Cardio; Cardioband
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: CB1-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED