VenTouch OUS Feasibility Study

Status Recruiting

Clinical Trial Summary

This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

Clinical Trial Description

This is a prospective, multi-center, single-arm 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 and deemed eligible per assessment by the inclusion/exclusion criteria. 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, 3, 6, 12, 24, and 36 months post-therapy adjustment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03616678
Study type	Interventional
Source	Mardil Medical
Contact	Sarah Hase, BS
Phone	763-710-4518
Email	shase@mardil.com
Status	Recruiting
Phase	N/A
Start date	March 25, 2019
Completion date	December 31, 2023

View Details

See also
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