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Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)

Functional Mitral Regurgitation Clinical Trial

Official title:
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study

Clinical Trial Summary

This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for treatment of moderate to moderate-severe functional mitral valve regurgitation [FMR].

Clinical Trial Description

This trial is a prospective, multi-center, single-arm First-In-Man Continuation study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation. The duration of the study follow-up is 36 months from the time of therapy adjustment. Data from this trial may be utilized in support of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be performed at 1 month, 3 months, 6 months, and 12, 24, and 36 months post-therapy adjustment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02671799
Study type Interventional
Source Mardil Medical
Contact
Status Active, not recruiting
Phase N/A
Start date January 2016
Completion date December 2020
View Details
See also
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