RECRUITING

MRI in Transcatheter Aortic Valve Replacement Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-21
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05603026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 105 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
  2. * Planned transfemoral TAVR; 18 years of age or older;
  3. * Able to give informed consent.
  1. * Patients with permanent pacemakers or implantable defibrillators;
  2. * Patients with non-MRI safe implants;
  3. * Severe claustrophobia;
  4. * Inability or contraindication to perform exercise bike stress test;
  5. * Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
  6. * Reduced left ventricular systolic function (\<40%);
  7. * History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
  8. * Significant non-treated coronary artery disease.

Contacts and Locations

Study Contact

Luis Dallan, MD
CONTACT
216-844-1000
luisdallan@yahoo.com
LaStasha Cowan
CONTACT
216-844-1000
lastasha.cowan@uhhospitals.org

Principal Investigator

Guilherme Attizzani, MD
PRINCIPAL_INVESTIGATOR
UH, Cleveland Medical Center
Sadeer Al-Kindi, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

  • Guilherme Attizzani, MD, PRINCIPAL_INVESTIGATOR, UH, Cleveland Medical Center
  • Sadeer Al-Kindi, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-11-21
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Aortic Valve Stenosis