A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Edwards Lifesciences
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Mortality
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Detailed Description
1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
- •Patient has senile degenerative aortic valve stenosis
- •Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
- •Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
Exclusion Criteria
- •Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- •Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
- •Patient has severe aortic valve regurgitation.
- •Patient has severe mitral valve regurgitation.
- •Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
- •Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Outcomes
Primary Outcomes
Mortality
Time Frame: 1 year
Number of Deaths
Secondary Outcomes
- Device Success(30 days)
- Hospitalization Length of Stay(7 days)