COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Study Overview
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Brief Summary
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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.

Official Title
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COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

Conditions
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Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration

Intervention / Treatment
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* Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
* Device: SAPIEN 3 THV
* Device: SAPIEN 3 Ultra RESILIA THV


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPVR - Main Cohort<br>Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). | Device: SAPIEN 3 THV<br>* SAPIEN 3 THV in the pulmonic position<br>|
| Experimental: TPVR - THV Registry<br>Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR. | Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV<br>* SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position<br>|
| Experimental: TPVR- S3UR Registry<br>Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). | Device: SAPIEN 3 Ultra RESILIA THV<br>* SAPIEN 3 Ultra RESILIA THV in the pulmonic position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Discharge, expected to be within 1-5 days post-procedure | 
| Mean RVOT gradient |  | 6 months | 
| Paravalvular and total PR |  | 6 months | 
| RVOT reintervention |  | 6 months | 
| Coronary artery compression requiring intervention |  | 30 days | 
| Major vascular complications |  | 30 days | 
| Life-threatening or disabling bleeding |  | 30 days | 
| THV frame fracture |  | 6 months | 
| Device-related endocarditis |  | 1 year | 
| Death (all-cause, procedural and device-related) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TPV, 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, TPVR, Tetralogy of Fallot, TPVI