MitraClip EXPAND G4 Study

Status Active, not recruiting

Clinical Trial Summary

This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

Clinical Trial Description

This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study. Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System. During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04177394
Study type	Observational
Source	Abbott Medical Devices
Contact
Status	Active, not recruiting
Phase
Start date	January 17, 2020
Completion date	March 2028

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Withdrawn	`NCT05040451` - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn	`NCT03714412` - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System	N/A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	`NCT05836532` - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed	`NCT05850026` - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
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