Clinical trial NCT00676689: COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Official title: Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Valve Insufficiency
Pulmonary Regurgitation
Dysfunctional RVOT Conduit
Pulmonary Obstruction
Pulmonary Stenosis
Keywords: Pulmonic
Regurgitation
Pulmonary Valve Conduit
Stenosis
Congenital Heart Defect
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.

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 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.

Eligibility 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).

Primary outcomes:
measure: Freedom From Device or Procedure Related Death or Reintervention
timeFrame: 1 year
Secondary outcomes:
measure: Freedom From MACCE
timeFrame: 6 Months
measure: Functional Improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital/ Children's Healthcare of Atlanta (CHOA)
state: Georgia
city: Chicago
country: United States
facility: Rush Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Children's Hospital of New York
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Rush University Medical Center
name: Ziyad M Hijazi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: