COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02744677 |
Recruitment Status :
Recruiting
First Posted : April 20, 2016
Last Update Posted : February 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Complex Congenital Heart Defect Dysfunctional RVOT Conduits or Previously Implanted Valve in the Pulmonic Position | Device: SAPIEN 3 THV | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 108 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV |
Actual Study Start Date : | July 5, 2016 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | December 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN 3 THV
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Device: SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position |
- 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 [ Time Frame: 1 year ]
- Device Success [ Time Frame: Immediately post-procedure ]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.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Weight ≥ 20 kg (44 lbs.)
- 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.
Exclusion Criteria:
- 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 (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets < 50,000 cells/µL) or any known blood clotting disorder
- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744677
Contact: Veronica Pettigrew, RN | 949-250-4116 | Veronica_Pettigrew@Edwards.com | |
Contact: John Tejeda | John_Tejeda@Edwards.com |
United States, California | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
University of California,, San Francisco (UCSF) | Recruiting |
San Francisco, California, United States, 94143 | |
United States, Georgia | |
Emory University/Children's Healthcare of Atlanta | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Kentucky | |
University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
United States, Missouri | |
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
Columbia University Medical Center/New York - Presbyterian Morgan Stanley Children's Hospital | Recruiting |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
The Lindner Research Center at Christ Hospital | Recruiting |
Cincinnati, Ohio, United States, 45219 | |
United States, Pennsylvania | |
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Utah | |
Intermountain Heart Institute (IMC) | Recruiting |
Murray, Utah, United States, 84107 | |
United States, Virginia | |
University of Virginia (UVA) | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
United States, Washington | |
University of Washington/Seattle Children's Hospital | Recruiting |
Seattle, Washington, United States, 98195 |
Principal Investigator: | D. Scott Lim, MD | University of Virginia Medical Center | |
Principal Investigator: | Vasilis Babaliaros, MD | Emory University Hospitals |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT02744677 |
Other Study ID Numbers: |
2015-01 |
First Posted: | April 20, 2016 Key Record Dates |
Last Update Posted: | February 5, 2020 |
Last Verified: | January 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
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 |
Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |