Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Valve Heart Disease Clinical Trial

— BASELINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843072
• Other study ID #: BASELINE TRIAL
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: Rutger-Jan Nuis, MD, PhD
• Phone: +31614858291
• Email: r.nuis[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Device:
• Evolut R/PRO bioprosthesis
To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses
• Edwards Sapien S3/Ultra bioprosthesis
Edwards Sapien S3/Ultra bioprosthesis

Locations

Country	Name	City	State
Austria	Vienna General Hospital	Vienna
Canada	St Paul's and Vancouver General Hospital	Vancouver
Denmark	Rigshospitalet	Copenhagen
France	Institut Cœur Poumon	Lille
Germany	Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany	Düsseldorf
Germany	University Hospital Mainz	Mainz
Greece	Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece	Athen
Italy	Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy	Brescia
Italy	University Hospital of Padova	Padua
Netherlands	Erasmus Medical Centre	Rotterdam
Portugal	Centro Hospitalar de Lisboa Ocidental	Lisbon
Switzerland	Inselspital, University Hospital	Bern
United Kingdom	Leeds Teaching Hospitals	Leeds
United States	Cedars Sinai	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  France,  Germany,  Greece,  Italy,  Netherlands,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days post transcatheter valve implantation
Secondary	Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems	Safety endpoint	1 year post transcatheter valve implantation