COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN Int… (NCT00676689) | Clinical Trial Compass
CompletedNot Applicable
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
United States81 participantsStarted 2008-04-08
Plain-language summary
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.
Who can participate
SexALL
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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.
What they're measuring
1
Freedom From Device or Procedure Related Death or Reintervention