Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis (BASELINE)
Primary Purpose
Valve Heart Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Evolut R/PRO bioprosthesis
Edwards Sapien S3/Ultra bioprosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Valve Heart Disease
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 65 years
- Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
- Written informed consent
Exclusion Criteria:
- Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
- Multi-valve defects requiring intervention
- Clinically unstable and/or inotropic/vasopressor /mechanical support.
- Known mural thrombus in the left ventricle
- Presence of a mechanical aortic valve
- History of recent (within 1 month) stroke or TIA
Sites / Locations
- Cedars Sinai
- Vienna General Hospital
- St Paul's and Vancouver General Hospital
- Rigshospitalet
- Institut Cœur Poumon
- Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, GermanyRecruiting
- University Hospital Mainz
- Department of Cardiology, Onassis Cardiac Surgery Center, Athens, GreeceRecruiting
- Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, ItalyRecruiting
- University Hospital of Padova
- Erasmus Medical CentreRecruiting
- Centro Hospitalar de Lisboa Ocidental
- Inselspital, University Hospital
- Leeds Teaching Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Evolut R/Pro bioprosthesis
Edwards Sapien S3/Ultra bioprosthesis
Arm Description
Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)
Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)
Outcomes
Primary Outcome Measures
Device success
Device success, definition modified from VARC-2 criteria:
Absence of procedural mortality AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
Secondary Outcome Measures
Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems
Safety endpoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04843072
Brief Title
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
Acronym
BASELINE
Official Title
Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
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
5. Study Description
Brief Summary
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses.
Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success.
Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro.
Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus.
Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO
Main study parameters/endpoints:
Primary endpoint is device success at 30 days
Defined by
Absence of procedural mortality AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valve Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evolut R/Pro bioprosthesis
Arm Type
Experimental
Arm Description
Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)
Arm Title
Edwards Sapien S3/Ultra bioprosthesis
Arm Type
Active Comparator
Arm Description
Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)
Intervention Type
Device
Intervention Name(s)
Evolut R/PRO bioprosthesis
Intervention Description
To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses
Intervention Type
Device
Intervention Name(s)
Edwards Sapien S3/Ultra bioprosthesis
Intervention Description
Edwards Sapien S3/Ultra bioprosthesis
Primary Outcome Measure Information:
Title
Device success
Description
Device success, definition modified from VARC-2 criteria:
Absence of procedural mortality AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
Time Frame
30 days post transcatheter valve implantation
Secondary Outcome Measure Information:
Title
Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems
Description
Safety endpoint
Time Frame
1 year post transcatheter valve implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 65 years
Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
Written informed consent
Exclusion Criteria:
Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
Multi-valve defects requiring intervention
Clinically unstable and/or inotropic/vasopressor /mechanical support.
Known mural thrombus in the left ventricle
Presence of a mechanical aortic valve
History of recent (within 1 month) stroke or TIA
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rutger-Jan Nuis, MD, PhD
Phone
+31614858291
Email
r.nuis@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Van Mieghem, MD, PhD
Organizational Affiliation
Erasmus Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rutger-Jan Nuis, MD, PhD
Organizational Affiliation
Erasmus Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
Facility Name
Vienna General Hospital
City
Vienna
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Hengstenberg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Christian Hengstenberg, MD, PhD
Facility Name
St Paul's and Vancouver General Hospital
City
Vancouver
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Webb, MD
First Name & Middle Initial & Last Name & Degree
John Webb, MD
First Name & Middle Initial & Last Name & Degree
David Wood, MD
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Sondergaard, MD
First Name & Middle Initial & Last Name & Degree
Lars Sondergaard, MD
Facility Name
Institut Cœur Poumon
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Van Belle, MD
First Name & Middle Initial & Last Name & Degree
Eric Van Belle, MD
Facility Name
Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Verena Veulemans, MD PhD
Facility Name
University Hospital Mainz
City
Mainz
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Von Bardeleben, MD
First Name & Middle Initial & Last Name & Degree
Stephan Von Bardeleben, MD
Facility Name
Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
City
Athen
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Iakovou, MD PhD
Facility Name
Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Maffeo, MD PhD
Facility Name
University Hospital of Padova
City
Padua
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giusepe Tarantini, MD
First Name & Middle Initial & Last Name & Degree
Giusepe Tarantini, MD
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger-Jan Nuis
Phone
+31614858291
Email
r.nuis@erasmusmc.nl
Facility Name
Centro Hospitalar de Lisboa Ocidental
City
Lisbon
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Teles, MD
First Name & Middle Initial & Last Name & Degree
Rui Teles, MD
Facility Name
Inselspital, University Hospital
City
Bern
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Pilgrim, MD
First Name & Middle Initial & Last Name & Degree
Thomas Pilgrim
Facility Name
Leeds Teaching Hospitals
City
Leeds
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Blackman, MD
First Name & Middle Initial & Last Name & Degree
Daniel Blackman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
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