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Clinical Trials/NCT05603026
NCT05603026RecruitingNot Applicable

Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance

University Hospitals Cleveland Medical Center2 sites in 1 country90 target enrollmentStarted: November 21, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
90
Locations
2
Primary Endpoint
Peak gradient

Study Overview

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.

Detailed Description

Project Overview/Summary Transcatheter aortic valve replacement (TAVR) is an alternative to open heart surgery for the treatment of severe aortic stenosis, and has recently been approved for low surgical risk patients. This has resulted in a shifting of TAVR patient demographics to younger and more active individuals. It is, therefore, imperative to deliver excellent hemodynamics after valve replacement to enable patients to recover an active lifestyle with enhanced exercise capacity. Several studies, mostly conducted with resting echocardiogram have suggested self-expanding valves (SEV) Evolut R, Evolut PRO, Evolut PRO+ (Medtronic , Minneapolis, MN) are associated with favorable hemodynamics, which may allow for improved exercise capacity in active patients.

Currently, there are different TAVR valves are commercially available in the United States. The Sapien 3 valve (Edwards Lifesciences, Irvine, CA) is an annular, balloon expandable valve (BEV) and the Evolut PRO+ valve features a supra-annular design and is a SEV. A recent study utilizing resting echocardiogram demonstrated better hemodynamics of supra-annular SEV compared with BEV, mostly in patients with smaller annuli.

Cardiac magnetic resonance (CMR) has emerged as an important tool in the non-invasive assessment of patients with valvular heart disease. While CMR has been used for the diagnosis and quantification of valvular heart disease, there is a paucity of data on its use for the assessment of valvular hemodynamics in the post TAVR setting. Furthermore, it would be of utmost importance to understand how these devices perform during exertion. Of note, cardiac magnetic resonance techniques permit quantification of the myocardial extracellular volume fraction (ECV), representing a surrogate marker of reactive interstitial fibrosis, and late gadolinium enhancement (LGE), representing replacement fibrosis or scar. ECV and LGE have been independently linked with heart failure (HF) events.

Several studies have demonstrated that non-invasive CMR can be used to calculate non-invasive pressure-volume loops using cine imaging and non-invasive brachial blood pressure. This enables assessment of myocardial performance beyond LVEF. CMR-derived myocardial stroke work is a novel method allowing non-invasive assessment of total active myocardial performance, including both constructive and wasted myocardial work. Specifically, changes in LV stroke work have been shown to carry important prognostic information following TAVR.

Hypothesis 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 105 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Peak gradient

Time Frame: 1-year

Mean AV gradient assessed by CMR (mmHg)

Mean gradient

Time Frame: 1-year

Mean AV gradient assessed by CMR (mmHg)

Effective orifice area (EOA)

Time Frame: Baseline, 30-days and 1-year

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

Secondary Outcomes

  • Exercise capacity post TAVR(30-days)
  • Myocardial extra-cellular volume fraction(1-year)
  • Mean gradient by echo(1-year)
  • Myocardial fibrosis(1-year)
  • Composite of morbidity and mortality associated with TAVR(1-year)
  • Stress CMR feasibility(30-days)
  • EOA by echo(1-year)
  • Ejection fraction by echo(1-year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guilherme Attizzani, MD

Physician

University Hospitals Cleveland Medical Center

Study Sites (2)

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