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Comparing Valve Types for Degenerated Bioprosthesis

This study is comparing two types of transcatheter (through a catheter, a thin tube) heart valves, the Evolut R/PRO and the Edwards Sapien S3/Ultra, for people whose existing surgical heart valve (bioprosthesis) is no longer working well. This procedure is called TAVI (transcatheter aortic valve implantation) and is often used for older patients with a condition called severe aortic stenosis (a narrowing of the heart's main artery). The study aims to see which valve works better at 30 days after implantation. You might be able to join if you are 65 years or older and have a failing surgical aortic bioprosthesis that your heart care team believes can be treated with TAVI. The study plans to enroll 400 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 400 participants to compare two different heart valve devices.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary success of the device will be measured at 30 days after the valve implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04843072

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

UNKNOWN
NAAges 65+InterventionalTreatment
Erasmus Medical Center
~400 participants
Updated 2022-07-27 on ClinicalTrials.gov
What's tested:Evolut R/PRO bioprosthesisEdwards Sapien S3/Ultra bioprosthesis

At a glance

Recruiting sites
4 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device success
Measured over 30 days post transcatheter valve implantation

Conditions

Valve Heart Disease

Explore related trials

Aortic Valve Disorder

Where it's being run

14 sites across 12 states
Germany2
Italy2
California1
Austria1
Canada1
Denmark1
France1
Greece1

Study leadership

  • Nicolas Van Mieghem, MD, PhD · PRINCIPAL_INVESTIGATOR · Erasmus Medical Centre
  • Rutger-Jan Nuis, MD, PhD · PRINCIPAL_INVESTIGATOR · Erasmus Medical Centre

Who to contact

Rutger-Jan Nuis, MD, PhD
[email protected]
+31614858291
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Device success30 days post transcatheter valve implantation

    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