COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV

Study Overview
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Brief Summary
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To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.

Detailed Description
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The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.

Official Title
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Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position

Conditions
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Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction, Pulmonary Stenosis

Intervention / Treatment
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* Device: SAPIEN Transcatheter Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Weight must be equal to or exceed 35 kilograms. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter. Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE. Subject is symptomatic as evidenced by cardiopulmonary exercise testing. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits. Catheterization is determined to be feasible by the treating physician. Exclusion Criteria Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) Previously enrolled in this study. Subject with pre-existing prosthetic heart valves in any position*. Severe chest wall deformity. Leukopenia (WBC<3000 mm3). Acute or chronic anemia (Hb <9 g/dL).
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAPIEN THV<br> | Device: SAPIEN Transcatheter Valve Implantation<br>* Device Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Device or Procedure Related Death or Reintervention |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From MACCE | Clinical Events Committee (CEC) adjudicated. | 6 Months | 
| Functional Improvement | Functional improvement at 6 months as defined by: a) Improved valve hemodynamics as demonstrated via Transthoracic Echo: i) Decrease in pulmonary regurgitation to mild or less for regurgitant lesions ii) Decrease in mean pulmonary gradient to less than 30 mmHg for stenotic lesions iii) Improvement in both i) and ii) above for mixed lesions b) Improvement of ≥ 1 NYHA functional class from baseline for patients with NYHA functional class ≥ 2 at baseline c) Freedom from recurrent pulmonary stenosis. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonic, Regurgitation, Pulmonary Valve Conduit, Stenosis, Congenital Heart Defect