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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02903420
Other study ID # EW-P-003
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date January 2026

Study information

Verified date September 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 38
Est. completion date January 2026
Est. primary completion date February 14, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Japan Keio University Hospital Shinjuku-Ku Tokyo
Japan Osaka University Hospital Suita Osaka

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Number of Deaths 1 year
Secondary 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
Secondary Hospitalization Length of Stay Discharge is defined as an average for 7 days 7 days
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