NCT05603026

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 24, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

October 24, 2022

Last Update Submit

December 14, 2025

Conditions

Aortic Valve Stenosis

Keywords

TAVRaortic stenosiscardiac magnetic resonanceexercise cardiovascular magnetic resonancemagnetic resonance imagingself-expanding valveballoon-expandable valveaortic bioprosthesis

Outcome Measures

Primary Outcomes (3)

  • Effective orifice area (EOA)

    Change in effective orifice area (EOA) assessed by CMR between baseline and 1-year follow up (cm2)

    Baseline, 30-days and 1-year

  • Mean gradient

    Mean AV gradient assessed by CMR (mmHg)

    1-year

  • Peak gradient

    Mean AV gradient assessed by CMR (mmHg)

    1-year

Secondary Outcomes (8)

  • Myocardial fibrosis

    1-year

  • Myocardial extra-cellular volume fraction

    1-year

  • Stress CMR feasibility

    30-days

  • Exercise capacity post TAVR

    30-days

  • Mean gradient by echo

    1-year

  • +3 more secondary outcomes

Study Arms (2)

TAVR using the self-expanding valve Evolut FX

ACTIVE COMPARATOR

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

Device: Self-expanding valve (Medtronic Evolut FX)

TAVR using the balloon-expandable valve Sapien 3 Ultra RESILIA

ACTIVE COMPARATOR

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

Device: Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)

Interventions

Self-expanding valve (Medtronic Evolut FX)DEVICE

Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve

TAVR using the self-expanding valve Evolut FX
Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)DEVICE

Bioprosthesis Edwards Sapien 3 Ultra valve

TAVR using the balloon-expandable valve Sapien 3 Ultra RESILIA

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Guilherme Attizzani, MD

    UH, Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

  • Sadeer Al-Kindi, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Dallan, MD

CONTACT

216-844-1000luisdallan@yahoo.com

LaStasha Cowan

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 2, 2022

Study Start

November 21, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)