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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation (TAVI)

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Keio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAPIEN 3; Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System	Device: Transcatheter Aortic Valve Implantation (TAVI); Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of Deaths	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	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).	30 days
Hospitalization Length of Stay	Discharge is defined as an average for 7 days	7 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Yoshiki Sawa, Osaka University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 14, 2019
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimated): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: EW-P-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes