COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
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| ClinicalTrials.gov Identifier: NCT02744677 |
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Recruitment Status :
Recruiting
First Posted : April 20, 2016
Last Update Posted : February 5, 2020
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Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
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Brief Summary:
The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% 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.
| 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 |
The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention. In addition patients with dysfunctional THV will be enrolled in a separate registry.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Veronica Pettigrew, RN | 949-250-4116 | Veronica_Pettigrew@Edwards.com | |
| Contact: John Tejeda | John_Tejeda@Edwards.com |
Locations
| 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 | |
Sponsors and Collaborators
Edwards Lifesciences
Investigators
| 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 |
Keywords provided by Edwards Lifesciences:
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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 |
Additional relevant MeSH terms:
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Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |