Supra-Annular vs. Annular ValvEs for Small Annuli (SAVE)
Primary Purpose
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement
Eligibility Criteria
Inclusion Criteria:
- Symptomatic subjects with severe native aortic valve stenosis
- aortic valve annulus mean diameter ≤23 mm
- Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- Institutional heart team determines that TAVR is appropriate
- Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Exclusion Criteria:
- Subject unable or unwilling to provide informed consent
- Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- Patients at high risk for coronary obstruction
- Patients with low-flow low gradient aortic valve stenosis
- patients at high risk for annular rupture with implantation of a balloon expandable valve
Sites / Locations
- Banner - University Medical Center, Phoenix campus
- Tucson Medical Center
- Delray Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Supra-Annular transcatheter heart valve
Annular transcatheter heart valve
Arm Description
Medtronic Evolut Pro Valve implantation
Edwards Sapien 3 Ultra implantation
Outcomes
Primary Outcome Measures
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Secondary Outcome Measures
VARC-2 30-day early safety and efficacy
All cause mortality stroke life-threatening bleeding acute kidney injury-stage 2 or 3 coronary artery obstruction major vascular complication valve-related dysfunction requiring repeat procedure NYHA class III or IV Requiring hospitalization for valve-related symptoms or worsening congestive heart failure
Pacemaker implantation
Clinical indication for permanent pacemaker insertion
Prosthetic Valve Dysfunction
Mean aortic valve gradient >= 20 mmHg
>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis
Full Information
NCT ID
NCT04372381
First Posted
April 27, 2020
Last Updated
January 25, 2023
Sponsor
Marvin Eng
Collaborators
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT04372381
Brief Title
Supra-Annular vs. Annular ValvEs for Small Annuli
Acronym
SAVE
Official Title
Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marvin Eng
Collaborators
William Beaumont Hospitals
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Detailed Description
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Keywords
Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-Label, Prospective randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supra-Annular transcatheter heart valve
Arm Type
Active Comparator
Arm Description
Medtronic Evolut Pro Valve implantation
Arm Title
Annular transcatheter heart valve
Arm Type
Active Comparator
Arm Description
Edwards Sapien 3 Ultra implantation
Intervention Type
Device
Intervention Name(s)
Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Intervention Description
Treatment of aortic valve stenosis using transcatheter aortic valve replacement
Primary Outcome Measure Information:
Title
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Time Frame
1 month
Secondary Outcome Measure Information:
Title
VARC-2 30-day early safety and efficacy
Description
All cause mortality stroke life-threatening bleeding acute kidney injury-stage 2 or 3 coronary artery obstruction major vascular complication valve-related dysfunction requiring repeat procedure NYHA class III or IV Requiring hospitalization for valve-related symptoms or worsening congestive heart failure
Time Frame
30 days
Title
Pacemaker implantation
Description
Clinical indication for permanent pacemaker insertion
Time Frame
30 days
Title
Prosthetic Valve Dysfunction
Description
Mean aortic valve gradient >= 20 mmHg
>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis
Time Frame
30 days and 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic subjects with severe native aortic valve stenosis
aortic valve annulus mean diameter ≤23 mm
Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
Institutional heart team determines that TAVR is appropriate
Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Exclusion Criteria:
Subject unable or unwilling to provide informed consent
Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
Renal function precluding the administration of iodinated contrast (eGFR < 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
Patients at high risk for coronary obstruction
Patients with low-flow low gradient aortic valve stenosis
patients at high risk for annular rupture with implantation of a balloon expandable valve
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marvin Eng, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner - University Medical Center, Phoenix campus
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Supra-Annular vs. Annular ValvEs for Small Annuli
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