NCT00676689

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Valve Insufficiency
• Pulmonary Regurgitation
• Dysfunctional RVOT Conduit
• Pulmonary Obstruction
• Pulmonary Stenosis

Interventions

Type	Name	Description
DEVICE	SAPIEN Transcatheter Valve Implantation	Device Implantation

Timeline

• Start date: 2008-04-08
• Primary completion: 2015-11-01
• Completion: 2019-12-31
• First posted: 2008-05-13
• Last updated: 2020-02-26
• Results posted: 2016-09-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study