Edwards Cardioband European Post-Market Study, MiBAND

Launched by EDWARDS LIFESCIENCES · Jul 16, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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