Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
Status: Active_not_recruiting
Location: See all (24) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 1 month
Healthy Volunteers: f
View:
• Neonates with Congenital Heart Disease (CHD) and ductal-dependent pulmonary blood flow requiring only a stable source of pulmonary blood flow as the initial palliation, for whom the clinical decision is made at the enrolling center that this is best achieved by either DAS or SPS.
• Age ≤ 30 days at time of index procedure (DAS or SPS).
Locations
United States
Alabama
University of Alabama
Birmingham
Arizona
Phoenix Children's Hospital
Phoenix
California
Children's Hospital Los Angeles
Los Angeles
UCSF Benioff Children's Hospitals
Oakland
Stanford Children's Health
Palo Alto
Colorado
Children's Hospital of Colorado
Aurora
Washington, D.c.
Children's National Medical Center
Washington D.c.
Florida
Joe DiMaggio Children's Hospital
Hollywood
Georgia
Children's Healthcare of Atlanta
Atlanta
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan
Ann Arbor
Missouri
Washington University School of Medicine
St Louis
North Carolina
Levine Children's Hospital
Charlotte
New York
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Le Bonheur Children's Hospital
Memphis
Texas
UT Southwestern Medical Center
Dallas
Texas Children's Hospital
Houston
Utah
Primary Children's Hospital
Salt Lake City
Wisconsin
Children's Wisconsin
Wauwatosa
Other Locations
Canada
Hospital for Sick Children
Toronto
Time Frame
Start Date: 2022-06-02
Completion Date: 2027-04-01
Participants
Target number of participants: 300
Treatments
Experimental: Ductal Artery Stent
Transcatheter ductal artery shunt will be placed by the interventional team. Drug-eluting coronary stent brand, length, and diameter are determined by the interventional team.
Experimental: Systemic-to-Pulmonary Artery Shunt
Surgical systemic-to-pulmonary artery shunt performed by the interventional team. SPS diameter, length, and material will be determined by the surgeon performing the intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Pediatric Heart Network
Leads: Carelon Research