Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 13
- Primary Endpoint
- Freedom From Device or Procedure Related Death or Reintervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Freedom From Device or Procedure Related Death or Reintervention
Time Frame: 1 year
Secondary Outcomes
- Freedom From MACCE(6 Months)
- Functional Improvement(6 months)