Cardiac MRI for Post-TAVR Paravalvular Leak Assessment

Completed

Conditions studied: Paravalvular Leak

In brief

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.

Key facts

Study ID

NCT03195114

Run by

University of Pittsburgh

People needed

15

Starts

2017-01-01

Expected to finish

2019-02-15

Last updated by the study team

2020-05-05

Who can join

Age: 60 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 required for both MDCT and CMR studies.
• Patients with metallic objects or implanted medical devices in the body (i.e. non-MRI conditional cardiac pacemaker or defibrillator, central nervous system aneurysm clips,implanted neural stimulators, cochlear implant, ocular foreign body [e.g., metal shavings], other implanted medical devices [e.g., drug infusion port], insulin pump, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants) which would exclude the participant from participating in the study. Verification of safety for MRI study should be checked for each one of the implanted medical devices at the website www.mrisafety.com.

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Houston Methodist DeBakey Heart & Vascular Center — Houston, Texas, United States
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec — Québec, Canada

Full record on ClinicalTrials.gov

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