Complex Congenital Heart DefectNCT02744677
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
A study testing SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV and SAPIEN 3 Ultra RESILIA THV in people with Complex Congenital Heart Defect and Dysfunctional RVOT Conduit, run by Edwards Lifesciences at 27 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency
- What is being tested?
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV and SAPIEN 3 Ultra RESILIA THV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 27 sitesUnited States
- Study dates
- 5 Jul 2016to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight ≥ 20 kg (44 lbs.)
- 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
- Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
- 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.
Who cannot join
- Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
- History of or active endocarditis (active treatment with antibiotics) within the past 180 days
- Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
- Inappropriate anatomy for femoral introduction and delivery of the study valve
- 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
- Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
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- Interventional/surgical procedures within 30 days prior to the TPVI procedure.
- Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
- History of or current intravenous drug use
- Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
- Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
- Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
- Participating in another investigational drug or device study that has not reached its primary endpoint.
- Female who is lactating or pregnant
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 21 recruiting
- Recruiting
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
- Recruiting
Childrens Hospital of Colorado
Aurora, Colorado, 80045
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
University of Virginia (UVA)
Charlottesville, Virginia, 22908
- Completed
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
Medical City Dallas
Dallas, Texas, 75230
- Recruiting
Children's Health System of Texas / UT Southwestern Medical Center
Dallas, Texas, 75235
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Withdrawn
University of Kentucky
Lexington, Kentucky, 40536
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Completed
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
LeBonheur Children's Hopsital
Memphis, Tennessee, 38103
- Recruiting
Intermountain Heart Institute (IMC)
Murray, Utah, 84107
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
- Recruiting
Columbia University Medical Center/NYPH
New York, New York, 10032
- Completed
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
- Recruiting
Methodist San Antonio
San Antonio, Texas, 78229
- Recruiting
University of California,, San Francisco (UCSF)
San Francisco, California, 94143
- Completed
University of Washington/Seattle Children's Hospital
Seattle, Washington, 98195
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
- Completed
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
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.
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Being tested
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- 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
- Medical subject headings
- Pulmonary Valve Insufficiency, Tetralogy of Fallot, Aortic Valve Disease, Pulmonary Atresia, Pulmonary Valve Stenosis, Truncus Arteriosus, Persistent, Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN 3/SAPIEN 3 Ultra RESILIA THVDevice
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THVDevice
SAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THVDevice
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
| Study group | Role | What they receive |
|---|---|---|
| TPVR - Main Cohort | Experimental | Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). Receives: Device: SAPIEN 3 THV |
| TPVR - THV Registry | Experimental | Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR. Receives: Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV |
| TPVR- S3UR Registry | Experimental | Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). Receives: Device: SAPIEN 3 Ultra RESILIA THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
THV dysfunction
Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient > 40 mmHg via TTE
Measured: 1 year
Secondary outcomes (10)
Device Success
Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient < 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.
Measured: Discharge, expected to be within 1-5 days post-procedure
Mean RVOT gradient
Measured: 6 months
Paravalvular and total PR
Measured: 6 months
RVOT reintervention
Measured: 6 months
Coronary artery compression requiring intervention
Measured: 30 days
Major vascular complications
Measured: 30 days
Life-threatening or disabling bleeding
Measured: 30 days
THV frame fracture
Measured: 6 months
Device-related endocarditis
Measured: 1 year
Death (all-cause, procedural and device-related)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start5 Jul 2016
- Primary completionDec 2026 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Congenital Heart DefectStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D. Scott Lim, MD, Principal investigator, University of British ColumbiaVasilis Babaliaros, MD, Principal investigator, Emory University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744677
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Dec 2025
- First submitted
- 12 Apr 2016
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36608435Hainstock MR, Fleming G, Kim D, Aboulhosn J, Levi D, Krasuski R, Sommer R, Torres AJ, Gray R, Kereiakes D, Leventhal A, Gillespie M, Szeto W, Zajarias A, Shahanavaz S, Steinberg ZL, Jones TK, Mahadevan VS, Moore P, Elmariah S, Shirali G, Li W, Babaliaros V, Lim DS; COMPASSION 3 Trial Executive Committee and Study Investigators. Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial. Circ Cardiovasc Interv. 2026 May;19(5):e016361. doi: 10.1161/CIRCINTERVENTIONS.125.016361. Epub 2026 Mar 26.
PubMed 41884901