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

Not Applicable

Completed

• Conditions: Pulmonary Valve Insufficiency; Pulmonary Obstruction; Pulmonary Stenosis; Dysfunctional RVOT Conduit; Pulmonary Regurgitation
• Interventions: Device: SAPIEN Transcatheter Valve Implantation

• Registration Number: NCT00676689
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Study Timeline

• Study Start: 2008-04-08
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Primary Completion: 2015-11
• Results First Submitted: 2016-05-04
• Results First Submitted QC: 2016-07-21
• Results First Posted: 2016-09-01
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAPIEN THV	SAPIEN Transcatheter Valve Implantation	-

Primary Outcome Measures

Name	Time	Method
Freedom From Device or Procedure Related Death or Reintervention	1 year

Secondary Outcome Measures

Name	Time	Method
Freedom From MACCE	6 Months	Clinical Events Committee (CEC) adjudicated.
Functional Improvement	6 months	Functional improvement at 6 months as defined by: a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis.

Trial Locations

Locations (7)

Emory University Hospital/ Children's Healthcare of Atlanta (CHOA); 🇺🇸 Atlanta, Georgia, United States

Miami Children's Hospital; 🇺🇸 Miami, Florida, United States

Rush Medical Center; 🇺🇸 Chicago, Illinois, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Children's Hospital of New York; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States