COMPASSION S3 Post-Approval Study

Status Recruiting

Clinical Trial Summary

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Clinical Trial Description

This is a single arm, prospective, multicenter post-approval study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04860765
Study type	Observational
Source	Edwards Lifesciences
Contact	Edwards THV Clinical Affairs
Phone	949-250-2500
Email	THV_CT.gov@Edwards.com
Status	Recruiting
Phase
Start date	April 13, 2021
Completion date	August 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05378386` - ALTERRA Post-Approval Study
Active, not recruiting	`NCT03441971` - Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction	N/A
Recruiting	`NCT02744677` - COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction	N/A
Active, not recruiting	`NCT02987387` - COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
Completed	`NCT01092442` - CryoValve SG Pulmonary Human Heart Valve Post Clearance Study	N/A
Completed	`NCT05090228` - Right Ventricle Remodeling After Pulmonary Valve Replacement and Percutaneous Pulmonary Valve Insertion
Completed	`NCT02656290` - COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement	N/A
Completed	`NCT00259207` - Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract	Phase 3
Recruiting	`NCT05809856` - Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve	N/A
Completed	`NCT02555319` - A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)	N/A
Completed	`NCT00676689` - COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV	N/A
Completed	`NCT00112320` - Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot	N/A