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

Edwards Lifesciences

Status: Completed

Conditions: Pulmonary Stenosis; Pulmonary Regurgitation; Dysfunctional RVOT Conduit; Pulmonary Obstruction; Pulmonary Valve Insufficiency

Treatments: Device: SAPIEN Transcatheter Valve Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676689

2006-09

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 81 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Weight must be equal to or exceed 35 kilograms.
2. In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
3. 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.
4. Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
5. 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.
6. 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.
7. Catheterization is determined to be feasible by the treating physician.

Exclusion Criteria

1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
2. Previously enrolled in this study.
3. Subject with pre-existing prosthetic heart valves in any position*.
4. Severe chest wall deformity.
5. Leukopenia (WBC<3000 mm3).
6. Acute or chronic anemia (Hb <9 g/dL).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

SAPIEN THV

Experimental group

Treatment:

Device: SAPIEN Transcatheter Valve Implantation