MRI in Transcatheter Aortic Valve Replacement Patients

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT05603026
Status
Recruiting
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Conditions

  • Aortic Valve Stenosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Not accepted

Interventions

  • Self-expanding valve (Medtronic Evolut FX) — DEVICE
    Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve
  • Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA) — DEVICE
    Bioprosthesis Edwards Sapien 3 Ultra valve

Study Details

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.

Key Dates

Start date
Nov 21, 2023
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Lastasha Cowan
[email protected]
216-844-1000

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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