Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Status Recruiting

Clinical Trial Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Clinical Trial Description

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03706833
Study type	Interventional
Source	Edwards Lifesciences
Contact	Edwards TMTT Clinical Affairs
Phone	(949) 250-2500
Email	TMTT_Clinical@edwards.com
Status	Recruiting
Phase	N/A
Start date	November 30, 2018
Completion date	April 30, 2030

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See also
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Not yet recruiting	`NCT06167213` - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral	N/A
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Withdrawn	`NCT05040451` - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn	`NCT03714412` - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System	N/A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
Completed	`NCT01841554` - Cardioband With Transfemoral Delivery System	N/A
Not yet recruiting	`NCT01431222` - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery	Phase 4
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

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial — CLASP IID/IIF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms