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REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

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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

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)

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

Trial documents
1

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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