Clinical Investigation for the Foldax Tria Mitral Valve- India

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.

Clinical Trial Description

The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year after implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06191718
Study type	Interventional
Source	Foldax, Inc
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 1, 2023
Completion date	December 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03278574` - Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease	N/A
Suspended	`NCT04960280` - A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease	N/A
Recruiting	`NCT05021614` - Valveclip® Transcatheter Mitral Valve Repair Study	N/A
Not yet recruiting	`NCT06465745` - AltaValve Pivotal Trial	N/A
Not yet recruiting	`NCT06167213` - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral	N/A
Withdrawn	`NCT05040451` - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn	`NCT03714412` - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System	N/A
Recruiting	`NCT02592889` - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy)	Phase 4
Completed	`NCT02355418` - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Not yet recruiting	`NCT01431222` - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery	Phase 4
Completed	`NCT01841554` - Cardioband With Transfemoral Delivery System	N/A
Not yet recruiting	`NCT03870516` - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery	N/A
Active, not recruiting	`NCT03230747` - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation	N/A
Enrolling by invitation	`NCT04031274` - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed	`NCT05850026` - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Completed	`NCT05836532` - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed	`NCT05836480` - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Recruiting	`NCT03975998` - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed	`NCT01162083` - Identifying an Ideal Cardiopulmonary Exercise Test Parameter	N/A
Suspended	`NCT00787293` - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients	Phase 2