Clinical trial NCT04860765: COMPASSION S3 Post-Approval Study
Official title: Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Complex Congenital Heart Defect
Dysfunctional RVOT Conduit
Pulmonary Valve Insufficiency
Pulmonary Valve Degeneration
Pulmonary Valve; Obstruction
Keywords: Transcatheter pulmonary valve replacement
Transcatheter pulmonary valve implantation
SAPIEN 3
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-04-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention

Brief 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.

Detailed description: This is a single arm, prospective, multicenter post-approval study.

Eligibility criteria: Inclusion Criteria:

1. Dysfunctional RVOT conduit or previously implanted surgical valve
2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections

Primary outcomes:
measure: Device Success
timeFrame: Discharge, expected to be within 1-5 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Oak Lawn
country: United States
facility: Advocate Childrens Hospital
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinatti Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Dell Children's
state: Texas
city: Dallas
country: United States
facility: Children's Health Dallas
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: