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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT00676689

Run by

Edwards Lifesciences

People needed

81

Starts

2008-04-08

Expected to finish

2019-12-31

Last updated by the study team

2020-02-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Miami Children's Hospital — Miami, Florida, United States
• Emory University Hospital/ Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia, United States
• Rush Medical Center — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospital of New York — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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