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REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

NCT ID: NCT02703311

Last Updated: 2020-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Mitral Valve Insufficiency Cardiac Valve Annuloplasty Mitral Valve Annuloplasty Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation

Keywords

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Valtech Cardio Cardioband Mitral Valve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cardioband procedure

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

Group Type OTHER

Cardioband

Intervention Type DEVICE

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

Interventions

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Cardioband

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bichat hospital

Paris, , France

Site Status

Bad Nauheim, Kerckhoff-Klinik

Bad Nauheim, , Germany

Site Status

Bonn University

Bonn, , Germany

Site Status

Koln, Universitätsklinikum

Cologne, , Germany

Site Status

Universitätsklinikum Gießen und Marburg

Giessen, , Germany

Site Status

University Hospital Halle (Saale)

Halle, , Germany

Site Status

Asklepios Klinik, St. Georg

Hamburg, , Germany

Site Status

Universitäres Herzzentrum Hamburg GmbH

Hamburg, , Germany

Site Status

Universitatsmedizin Mainz

Mainz, , Germany

Site Status

Hospital san raffaele

Milan, , Italy

Site Status

Countries

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France Germany Italy

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CB1-3

Identifier Type: -

Identifier Source: org_study_id