search
Back to results

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
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valve Heart Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 24, 2021
Last Updated
July 25, 2022
Sponsor
Erasmus Medical Center
search

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

We'll reach out to this number within 24 hrs