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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

NCT number NCT04860765
Study type Observational
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone 949-250-2500
Email [email protected]
Status Recruiting
Start date April 13, 2021
Completion date August 2030

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02555319 - A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV) 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
Active, not recruiting 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
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