REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

Edwards Lifesciences

Status: Terminated

Conditions: Heart Valve Diseases; Mitral Valve Insufficiency; Mitral Valve Annuloplasty; Mitral Regurgitation; Cardiovascular Diseases; Heart Diseases; Cardiac Valve Annuloplasty

Treatments: Device: Cardioband

Study type: Interventional

Funder types: Industry

Identifiers

NCT02703311

CB1-3

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Cardioband procedure

Other group

Description:

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

Treatment:

Device: Cardioband