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

Not Applicable

Active, not recruiting

• Conditions: Aortic Stenosis
• Interventions: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Registration Number: NCT02903420
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Primary Completion: 2019-02-14
• Results First Submitted: 2020-09-03
• Results First Submitted QC: 2020-09-03
• Results First Posted: 2020-09-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Number of Deaths

Secondary Outcome Measures

Name	Time	Method
Device Success	30 days	Number of patients with device success, defined as absence of procedural mortality, correct positioning of a study valve into the proper anatomical location, and intended performance of the study valve (no prosthesis-patient mismatch and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, and no moderate or severe prosthetic valve regurgitation).
Hospitalization Length of Stay	7 days	Discharge is defined as an average for 7 days

Trial Locations

Locations (2)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan