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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02903420
• Other study ID #: EW-P-003
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

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