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

July 25, 2022 updated by: Nicolas van Mieghem, Erasmus Medical Center

Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria
        • Not yet recruiting
        • Vienna General Hospital
        • Contact:
          • Christian Hengstenberg, MD, PhD
        • Principal Investigator:
          • Christian Hengstenberg, MD, PhD
  • Canada
      • Vancouver, Canada
        • Not yet recruiting
        • St Paul's and Vancouver General Hospital
        • Contact:
          • John Webb, MD
        • Principal Investigator:
          • David Wood, MD
  • Denmark
      • Copenhagen, Denmark
        • Not yet recruiting
        • Rigshospitalet
        • Contact:
          • Lars Sondergaard, MD
        • Principal Investigator:
          • Lars Sondergaard, MD
  • France
      • Lille, France
        • Not yet recruiting
        • Institut Coeur Poumon
        • Contact:
          • Eric van Belle, MD
        • Principal Investigator:
          • Eric Van Belle, MD
  • Germany
      • Düsseldorf, Germany
        • Recruiting
        • Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
        • Contact:
          • Verena Veulemans, MD PhD
      • Mainz, Germany
        • Not yet recruiting
        • University Hospital Mainz
        • Principal Investigator:
          • Stephan von Bardeleben, MD
  • Greece
      • Athen, Greece
        • Recruiting
        • Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
        • Contact:
          • Ioannis Iakovou, MD PhD
  • Italy
      • Brescia, Italy
        • Recruiting
        • Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
        • Contact:
          • Diego Maffeo, MD PhD
      • Padua, Italy
        • Not yet recruiting
        • University Hospital of Padova
        • Contact:
          • Giusepe Tarantini, MD
        • Principal Investigator:
          • Giusepe Tarantini, MD
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medical Centre
        • Contact:
  • Portugal
      • Lisbon, Portugal
        • Not yet recruiting
        • Centro Hospitalar de Lisboa Ocidental
        • Contact:
          • Rui Teles, MD
        • Principal Investigator:
          • Rui Teles, MD
  • Switzerland
      • Bern, Switzerland
        • Not yet recruiting
        • Inselspital, University Hospital
        • Contact:
          • Thomas Pilgrim, MD
        • Principal Investigator:
          • Thomas Pilgrim
  • United Kingdom
      • Leeds, United Kingdom
        • Not yet recruiting
        • Leeds Teaching Hospitals
        • Contact:
          • Daniel Blackman, MD
        • Principal Investigator:
          • Daniel Blackman, MD
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai
        • Contact:
          • Raj Makkar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post transcatheter valve implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year post transcatheter valve implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Nicolas Van Mieghem, MD, PhD, Erasmus Medical Centre
  • Principal Investigator: Rutger-Jan Nuis, MD, PhD, Erasmus Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASELINE TRIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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