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Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis (BASELINE)

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ClinicalTrials.gov Identifier: NCT04843072
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Nicolas van Mieghem, Erasmus Medical Center

Study Description
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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:

  1. 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
  2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

Condition or disease Intervention/treatment Phase
Valve Heart Disease Device: Evolut R/PRO bioprosthesis Device: Edwards Sapien S3/Ultra bioprosthesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Evolut R/Pro bioprosthesis
Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)
 Device: Evolut R/PRO bioprosthesis
To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses
Active Comparator: Edwards Sapien S3/Ultra bioprosthesis
Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)
 Device: Edwards Sapien S3/Ultra bioprosthesis
Edwards Sapien S3/Ultra bioprosthesis


Outcome Measures
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Primary Outcome Measures :
  1. Device success [ Time Frame: 30 days post transcatheter valve implantation ]

    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 :
  1. Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems [ Time Frame: 1 year post transcatheter valve implantation ]
    Safety endpoint


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843072


Contacts
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Contact: Rutger-Jan Nuis, MD, PhD +31614858291 r.nuis@erasmusmc.nl

Locations
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United States, California
Cedars Sinai Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Raj Makkar, MD         
Principal Investigator: Raj Makkar, MD         
Austria
Vienna General Hospital Not yet recruiting
Vienna, Austria
Contact: Christian Hengstenberg, MD, PhD         
Principal Investigator: Christian Hengstenberg, MD, PhD         
Canada
St Paul's and Vancouver General Hospital Not yet recruiting
Vancouver, Canada
Contact: John Webb, MD         
Principal Investigator: John Webb, MD         
Principal Investigator: David Wood, MD         
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Lars Sondergaard, MD         
Principal Investigator: Lars Sondergaard, MD         
France
Institut Cœur Poumon Not yet recruiting
Lille, France
Contact: Eric Van Belle, MD         
Principal Investigator: Eric Van Belle, MD         
Germany
University Hospital Mainz Not yet recruiting
Mainz, Germany
Contact: Stephan Von Bardeleben, MD         
Principal Investigator: Stephan Von Bardeleben, MD         
Italy
University Hospital of Padova Not yet recruiting
Padua, Italy
Contact: Giusepe Tarantini, MD         
Principal Investigator: Giusepe Tarantini, MD         
Netherlands
Erasmus Medical Centre Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Rutger-Jan Nuis    +31614858291    r.nuis@erasmusmc.nl   
Portugal
Centro Hospitalar de Lisboa Ocidental Not yet recruiting
Lisbon, Portugal
Contact: Rui Teles, MD         
Principal Investigator: Rui Teles, MD         
Switzerland
Inselspital, University Hospital Not yet recruiting
Bern, Switzerland
Contact: Thomas Pilgrim, MD         
Principal Investigator: Thomas Pilgrim         
United Kingdom
Leeds Teaching Hospitals Not yet recruiting
Leeds, United Kingdom
Contact: Daniel Blackman, MD         
Principal Investigator: Daniel Blackman, MD         
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Nicolas Van Mieghem, MD, PhD Erasmus Medical Centre
Study Director: Rutger-Jan Nuis, MD, PhD Erasmus Medical Centre
More Information
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Responsible Party: Nicolas van Mieghem, Prof. dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04843072    
Other Study ID Numbers: BASELINE TRIAL
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases