Recruiting NCT02744677
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV.
- Who it may be relevant to
- Registry conditions: Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Overview
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.
Interventions
- Device SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position - Device SAPIEN 3 THV
SAPIEN 3 THV in the pulmonic position - Device SAPIEN 3 Ultra RESILIA THV
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Primary outcome measures
- THV dysfunction [Time frame: 1 year]
Secondary outcome measures (10)
- Device Success [Time frame: Discharge, expected to be within 1-5 days post-procedure]
- Mean RVOT gradient [Time frame: 6 months]
- Paravalvular and total PR [Time frame: 6 months]
- RVOT reintervention [Time frame: 6 months]
- Coronary artery compression requiring intervention [Time frame: 30 days]
- Major vascular complications [Time frame: 30 days]
- Life-threatening or disabling bleeding [Time frame: 30 days]
- THV frame fracture [Time frame: 6 months]
- Device-related endocarditis [Time frame: 1 year]
- Death (all-cause, procedural and device-related) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
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, 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 27 centers
- University of Alabama at Birmingham — Birmingham
- Arkansas Children's Hospital — Little Rock
- University of California, Los Angeles — Los Angeles
- University of California,, San Francisco (UCSF) — San Francisco
- Childrens Hospital of Colorado — Aurora
- Emory University/Children's Healthcare of Atlanta — Atlanta
- University of Kentucky — Lexington
- Massachusetts General Hospital — Boston
- … and 19 more centers
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. PMID 36608435
- Hainstock 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 PMID 41884901
Identifiers
NCT: NCT02744677 · 2015-01