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

NCT ID: NCT02903420

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2026-01-31

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.

Conditions

Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAPIEN 3

Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System

Group Type: EXPERIMENTAL

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type: DEVICE

Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.

Interventions

Transcatheter Aortic Valve Implantation (TAVI)

Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshiki Sawa

Role: PRINCIPAL_INVESTIGATOR

Osaka University Hospital

Locations

Osaka University Hospital

Suita, Osaka, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EW-P-003

Identifier Type: -

Identifier Source: org_study_id