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

Erasmus University

Status: Enrolling

Conditions: Valve Heart Disease

Treatments: Device: Edwards Sapien S3/Ultra bioprosthesis; Device: Evolut R/PRO bioprosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04843072

BASELINE TRIAL

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Evolut R/Pro bioprosthesis

Experimental group

Description:

Study subjects will receive a self-expanding-valve (either the Evolut R or PRO device)

Treatment:

Device: Evolut R/PRO bioprosthesis

Edwards Sapien S3/Ultra bioprosthesis

Active Comparator group

Description:

Study subjects will receive a balloon-expanding-valve (either the Edwards Sapien S3 or Ultra)

Treatment:

Device: Edwards Sapien S3/Ultra bioprosthesis