Cardiac MRI for Post-TAVR Paravalvular Leak Assessment
United States, Canada15 participantsStarted 2017-01-01
Plain-language summary
The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging methods; and c) correlate the severity of PVL with post-TAVR changes in LV remodeling and clinical outcomes.
Who can participate
Age range60 Years – 100 Years
SexALL
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Inclusion Criteria:
Subjects will be considered for study participation if they meet all of the following inclusion criteria:
* Patient ≥ 60 years of age has undergone commercial TAVR implant with Evolut R or Evolut PRO bioprosthesis within prior 25-45 days.
* Patient has ≥ mild PVL on TTE study performed at approximately the one (1) month post-TAVR (regular clinical follow-up visit taking place within prior 25-45 days post-TAVR)
* The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Eligible patients from the three (3) participating institutions (University of Pittsburgh, Pittsburgh, PA; Methodist Hospital, Houston, TX and Quebec Heart \& Lung Institute, Quebec, Canada) who have received TAVR with Evolut R or Evolut PRO will be screened for this study. All patients should be willing and able to provide a written informed consent for this study.
Exclusion Criteria:
* Patients with unstable condition and/or with implanted permanent cardiac device such as implantable cardiac defibrillators, cardiac resynchronization device, etc. MRI-conditional pacemaker devices would not represent an exclusion given the proven safety of these devices at 1.5 Tesla magnetic field strength.
* Patients treated with valve-in-valve implantation technique to address moderate-severe PVL and/or prosthetic aortic valve dysfunction.
* Patients with significant interval cognitive decline post-TAVR, unable to follow instructions re…