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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-08

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Valve Insufficiency Pulmonary Regurgitation Dysfunctional RVOT Conduit Pulmonary Obstruction Pulmonary Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAPIEN THV

Group Type EXPERIMENTAL

SAPIEN Transcatheter Valve Implantation

Intervention Type DEVICE

Device Implantation

Interventions

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SAPIEN Transcatheter Valve Implantation

Device Implantation

Intervention Type DEVICE

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No