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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |