Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Valve Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolut R/Pro bioprosthesis

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

Group Type EXPERIMENTAL

Evolut R/PRO bioprosthesis

Intervention Type DEVICE

To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses

Edwards Sapien S3/Ultra bioprosthesis

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

Group Type ACTIVE_COMPARATOR

Edwards Sapien S3/Ultra bioprosthesis

Intervention Type DEVICE

Edwards Sapien S3/Ultra bioprosthesis

Interventions

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Evolut R/PRO bioprosthesis

To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses

Intervention Type DEVICE

Edwards Sapien S3/Ultra bioprosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No