NCT02903420

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

A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation (TAVI)	Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-02-14
• Completion: 2026-01-01
• First posted: 2016-09-16
• Last updated: 2024-09-25
• Results posted: 2020-09-24

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated device study