This trial is active, not recruiting.

Conditions pulmonary valve insufficiency, pulmonary regurgitation, dysfunctional rvot conduit, pulmonary obstruction, pulmonary stenosis
Treatment sapien transcatheter valve implantation
Sponsor Edwards Lifesciences
Start date April 2008
End date November 2015
Trial size 70 participants
Trial identifier NCT00676689, 2006-09


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
sapien transcatheter valve implantation
Device Implantation

Primary Outcomes

Freedom from device or procedure related death and/or reoperation at 1 year.
time frame: 1 year

Secondary Outcomes

Freedom from MACCE
time frame: 6 Months
Functional Improvement
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

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). 7. Platelet count <100,000 cells/mm3. 8. In the judgment of the Investigator, percutaneous introduction and delivery of the SAPIEN THV device is not feasible. 9. Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason. 10. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 11. History of, or active endocarditis.* 12. History of, or current intravenous drug abuse. 13. A known hypersensitivity to aspirin or heparin. 14. Currently participating in an investigational drug or another device study. [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.] 15. Major or progressive noncardiac disease resulting in a life expectancy of <1yr. 16. Obstruction of the central veins preventing advancement of the pulmonic bioprosthesis delivery system to the heart. 17. Positive urine or serum pregnancy test in female subjects of child-bearing potential. 18. Right ventricular outflow tract aneurysm. 19. Ileofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath. 20. Need for concomitant interventional procedures such as ASD or VSD closure. 21. Previous angiographic evidence of coronary artery compression.

Additional Information

Official title Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
Principal investigator Ziyad M Hijazi, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.