Clinical trial NCT02744677: COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Official title: COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Congenital Heart Defect
Dysfunctional RVOT Conduit
Pulmonary Valve Insufficiency
Pulmonary Valve Degeneration
Keywords: Tetralogy of Fallot
Aortic Valve Defect/Disease Resulting in Ross Procedure
Pulmonary Atresia
Pulmonary Stenosis
Truncus Arteriosus
Transposition of the Great Arteries
Transcatheter pulmonary valve implantation
Transcatheter pulmonary valve replacement
TPV
TPVR
TPVI
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.


Eligibility criteria: Inclusion Criteria:

1. Weight ≥ 20 kg (44 lbs.)
2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
4. The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
4. Inappropriate anatomy for femoral introduction and delivery of the study valve
5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
9. History of or current intravenous drug use
10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
13. Participating in another investigational drug or device study that has not reached its primary endpoint.
14. Female who is lactating or pregnant

Primary outcomes:
measure: THV dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: Device Success
timeFrame: Discharge, expected to be within 1-5 days post-procedure
measure: Mean RVOT gradient
timeFrame: 6 months
measure: Paravalvular and total PR
timeFrame: 6 months
measure: RVOT reintervention
timeFrame: 6 months
measure: Coronary artery compression requiring intervention
timeFrame: 30 days
measure: Major vascular complications
timeFrame: 30 days
measure: Life-threatening or disabling bleeding
timeFrame: 30 days
measure: THV frame fracture
timeFrame: 6 months
measure: Device-related endocarditis
timeFrame: 1 year
measure: Death (all-cause, procedural and device-related)
timeFrame: 1 year
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California,, San Francisco (UCSF)
state: California
city: Aurora
country: United States
facility: Childrens Hospital of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University/Children's Healthcare of Atlanta
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Research Center at Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: LeBonheur Children's Hopsital
state: Tennessee
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Children's Health System of Texas / UT Southwestern Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist San Antonio
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Institute (IMC)
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia (UVA)
state: Virginia
city: Seattle
country: United States
facility: University of Washington/Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Virginia Medical Center
name: D. Scott Lim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University Hospitals
name: Vasilis Babaliaros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim DS, Kim D, Aboulhosn J, Levi D, Fleming G, Hainstock M, Sommer R, Torres AJ, Zhao Y, Shirali G, Babaliaros V. Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Am J Cardiol. 2023 Mar 1;190:102-109. doi: 10.1016/j.amjcard.2022.12.010. Epub 2023 Jan 4.