Clinical Trials Logo
  1. Home
  2. Pulmonary Stenosis
  3. NCT00676689

COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

Pulmonary Regurgitation Clinical Trial

Official title:
Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

Clinical Trial Summary

To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.

Clinical Trial Description

The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00676689
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date April 8, 2008
Completion date December 31, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05077774 - Harmony TPV Post-Approval Study N/A
Recruiting NCT02590679 - Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p Phase 2/Phase 3
Recruiting NCT05378386 - ALTERRA Post-Approval Study
Recruiting NCT04570163 - Berlin Registry of Right Heart Interventions
Recruiting NCT06010563 - VenusP-Valve Pivotal Study (PROTEUS STUDY) N/A
Active, not recruiting NCT03471936 - Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease N/A
Active, not recruiting NCT02979587 - The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study N/A
Completed NCT01356108 - Pulmonic Valve REplacement Multi-discIpline EMEA Registry
Completed NCT01824160 - Pulmonary Artery Repair With Covered Stents N/A
Active, not recruiting NCT03130777 - ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent N/A
Active, not recruiting NCT02846753 - Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts N/A
Recruiting NCT04084132 - Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation N/A