Recruiting

Observational Study

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT05603026

Conditions

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Self-expanding valve (Medtronic Evolut FX)

Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)

Study Details

Brief summary:

The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.

Conditions

Aortic Valve Stenosis

Study ID

NCT05603026

Start date

Nov 21, 2023

Status verified date

Dec, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
  • Planned transfemoral TAVR; 18 years of age or older;
  • Able to give informed consent.

Exclusion Criteria:

  • Patients with permanent pacemakers or implantable defibrillators;
  • Patients with non-MRI safe implants;
  • Severe claustrophobia;
  • Inability or contraindication to perform exercise bike stress test;
  • Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
  • Reduced left ventricular systolic function (<40%);
  • History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
  • Significant non-treated coronary artery disease.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TAVR using the self-expanding valve Evolut FX

Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Medtronic Evolut FX supra-annular self-expanding valve

active comparator: TAVR using the balloon-expandable valve Sapien 3 Ultra RESILIA

Transcatheter aortic valve replacement (TAVR) using the bioprosthesis Edwards Sapien 3 Ultra valve

Interventions

Self-expanding valve (Medtronic Evolut FX)

Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve

Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)

Bioprosthesis Edwards Sapien 3 Ultra valve

Primary outcome measure

  • Effective orifice area (EOA) [ Time Frame: Baseline, 30-days and 1-year ]
  • Mean gradient [ Time Frame: 1-year ]
  • Peak gradient [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Luis Dallan, MD

216-844-1000luisdallan@yahoo.com

LaStasha Cowan

216-844-1000lastasha.cowan@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lastasha Cowan

216-844-1000lastasha.cowan@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • TAVR
  • aortic stenosis
  • cardiac magnetic resonance
  • exercise cardiovascular magnetic resonance
  • magnetic resonance imaging
  • self-expanding valve
  • balloon-expandable valve
  • aortic bioprosthesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-12-17.