NCT01772108

A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.

Detailed description

This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective was to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients. Due to lower than expected recruitment rate, Abbott Vascular sponsorship of the trial was terminated early.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	MitraClip	The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2013-01-21
• Last updated: 2018-11-07

Locations

29 sites across 10 countries: Austria, Belgium, Denmark, Finland, Germany, Italy, Netherlands, Spain, Sweden, Switzerland