Back to resultsA Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
Primary Purpose
Aortic Stenosis
Status
Active
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Transcatheter Aortic Valve Implantation (TAVI)
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
Eligibility Criteria
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.
Sites / Locations
- Osaka University Hospital
- Keio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAPIEN 3
Arm Description
Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System
Outcomes
Primary Outcome Measures
Mortality
Number of Deaths
Secondary Outcome Measures
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).
Hospitalization Length of Stay
Discharge is defined as an average for 7 days
Full Information
NCT ID
NCT02903420
First Posted
August 22, 2016
Last Updated
September 19, 2023
Sponsor
Edwards Lifesciences
1. Study Identification
Unique Protocol Identification Number
NCT02903420
Brief Title
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
Official Title
A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAPIEN 3
Arm Type
Experimental
Arm Description
Transcatheter Aortic Valve Implantation (TAVI) with the Edwards SAPIEN 3 Transcatheter Heart Valve and Delivery System
Intervention Type
Device
Intervention Name(s)
Transcatheter Aortic Valve Implantation (TAVI)
Intervention Description
Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
Primary Outcome Measure Information:
Title
Mortality
Description
Number of Deaths
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Device Success
Description
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).
Time Frame
30 days
Title
Hospitalization Length of Stay
Description
Discharge is defined as an average for 7 days
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiki Sawa
Organizational Affiliation
Osaka University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
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