AltaValve Early Feasibility Study Protocol

Status Recruiting

Clinical Trial Summary

Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03997305
Study type	Interventional
Source	4C Medical Technologies, Inc.
Contact	Adam Lawrence
Phone	+1-727-318-2203
Email	AltaValveEFS@4CMed.com
Status	Recruiting
Phase	N/A
Start date	December 4, 2019
Completion date	September 2025

View Details

See also
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Not yet recruiting	`NCT06167213` - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral	N/A
Not yet recruiting	`NCT06465745` - AltaValve Pivotal Trial	N/A
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Withdrawn	`NCT03714412` - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System	N/A
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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