Brief Title
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
Official Title
A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
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.
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.
Study Type
Interventional
Primary Outcome
Mortality
Secondary Outcome
Device Success
Condition
Aortic Stenosis
Intervention
Transcatheter Aortic Valve Implantation (TAVI)
Study Arms / Comparison Groups
SAPIEN 3
Description: Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
38
Start Date
September 2016
Completion Date
July 2022
Primary Completion Date
June 2018
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.
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Yoshiki Sawa, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02903420
Organization ID
EW-P-003
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Yoshiki Sawa, Principal Investigator, Osaka University Hospital
Verification Date
September 2021