Edwards Cardioband European Post-Market Study, MiBAND

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Mitral Repair; Mitral Insufficiency; Mitral Regurgitation; Edwards Cardioband; Annuloplasty; Mitral Valve

Treatments: Device: Edwards Cardioband System

Study type: Observational

Funder types: Industry

Identifiers

NCT03600688

2017-10

Details and patient eligibility

About

To demonstrate reduction of MR with durable performance and im-provements in functional status

Full description

MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Age ≥ 18 years;
• MR (≥ 2+ by echocardiography);
• Patient is eligible to receive the Edwards Cardioband Mitral System

Main Exclusion Criteria:

• Active bacterial endocarditis
• Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue
• Heavily calcified annulus or leaflets
• Patients in whom transesophageal echocardiography is contraindicated
• Patients who cannot tolerate an anticoagulation/antiplatelet regimen
• Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated.
• Pre-existing prosthetic heart valve or annuloplasty in the Mitral position
• Life expectancy of less than twelve months
• Patient is pregnant or lactating