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

NCT02903420 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: EW-P-003
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Number of Deaths

  1 year

Secondary Outcomes (2)

• Device Success

  30 days

• Hospitalization Length of Stay

  7 days

Study Arms (1)

SAPIEN 3

EXPERIMENTAL

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

Device: Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) DEVICE

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

SAPIEN 3

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with planned concomitant surgical or transcatheter ablation for atrial fibrillation.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: Director of Research
• Organization: Edwards Lifesciences

THV_CT.gov@edwards.com

949-250-2500

Study Officials

• Yoshiki Sawa

  Osaka University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: February 14, 2019
• Study Completion: January 1, 2026
• Last Updated: September 25, 2024
• Results First Posted: September 24, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)