N/A
Completed N=81
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Pulmonary Valve Insufficiency · Pulmonary Regurgitation · Dysfunctional RVOT Conduit · Pulmonary Obstruction
Source: ClinicalTrials.gov NCT00676689 ↗
Enrolled (actual)
81
Serious AEs
48.1%
Results posted
Sep 2016
Primary outcomePrimary: Freedom From Device or Procedure Related Death or Reintervention — 97.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Device or Procedure Related Death or Reintervention |
97.1 | — |
| SECONDARY Freedom From MACCE |
94.1 | — |
| SECONDARY Functional Improvement |
51 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00676689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.