A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

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

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 2020