NCT02703311

REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-11-01
• Completion: 2018-12-01
• First posted: 2016-03-09
• Last updated: 2020-11-09
• Results posted: 2020-11-09

Locations

10 sites across 3 countries: France, Germany, Italy