Clinical trial NCT04843072: Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
Official title: Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Valve Heart Disease
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Device success
timeFrame: 30 days post transcatheter valve implantation
Secondary outcomes:
measure: Composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems
timeFrame: 1 year post transcatheter valve implantation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Vienna
country: Austria
facility: Vienna General Hospital
city: Vancouver
country: Canada
facility: St Paul's and Vancouver General Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille
country: France
facility: Institut Cœur Poumon
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany
city: Mainz
country: Germany
facility: University Hospital Mainz
city: Athen
country: Greece
facility: Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece
city: Brescia
country: Italy
facility: Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy
city: Padua
country: Italy
facility: University Hospital of Padova
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
city: Bern
country: Switzerland
facility: Inselspital, University Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
Study officials:
affiliation: Erasmus Medical Centre
name: Nicolas Van Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Centre
name: Rutger-Jan Nuis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: