Status:
COMPLETED
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Lead Sponsor:
Edwards Lifesciences
Conditions:
Pulmonary Valve Insufficiency
Pulmonary Regurgitation
Eligibility:
All Genders
Phase:
NA
Brief 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 regurg...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00676689
Start Date
April 8 2008
End Date
December 31 2019
Last Update
February 26 2020
Active Locations (7)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Miami Children's Hospital
Miami, Florida, United States, 33155
3
Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, United States, 30341
4
Rush Medical Center
Chicago, Illinois, United States, 60612