REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Not Applicable

Terminated

• Conditions: Mitral Valve Insufficiency; Cardiac Valve Annuloplasty; Heart Diseases; Heart Valve Diseases; Mitral Valve Annuloplasty; Cardiovascular Diseases; Mitral Regurgitation
• Interventions: Device: Cardioband

• Registration Number: NCT02703311
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Study Start: 2016-08
• Primary Completion: 2017-11
• Study Completion: 2018-12
• Results First Submitted: 2020-09-03
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Results First Posted: 2020-11-09
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardioband procedure	Cardioband	Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Asklepios Klinik, St. Georg; 🇩🇪 Hamburg, Germany

Hospital san raffaele; 🇮🇹 Milano, Italy

University Hospital Halle (Saale); 🇩🇪 Halle, Germany

Koln, Universitätsklinikum; 🇩🇪 Koln, Germany

Universitatsmedizin Mainz; 🇩🇪 Mainz, Germany

Universitäres Herzzentrum Hamburg GmbH; 🇩🇪 Hamburg, Germany

Bad Nauheim, Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Bonn University; 🇩🇪 Bonn, Germany

Universitätsklinikum Gießen und Marburg; 🇩🇪 Giessen, Germany

Bichat hospital; 🇫🇷 Paris, France