Cardiac MRI for Post-TAVR Paravalvular Leak Assessment

NCT03195114 | Completed DMC

• 1 other identifier: PRO15050330
• Study Type: observational
• Target: 15
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Paravalvular Leak

Keywords

post TAVR quantification; cardiac MRI; echocardiography; biomarkers

Outcome Measures

Primary Outcomes (1)

• PVL severity regression

  To test that PVL severity, assessed by CMR using regurgitant fraction and regurgitant volume, changes and regresses over a 6-month period post-TAVR (comparing those measurements at 1-month and 7-months post-TAVR).

  up to 7-months post-TAVR

Secondary Outcomes (1)

• Intra- and inter-observer variability of PVL severity assessment

  1-month and 7-months post-TAVR

Other Outcomes (1)

• PVL severity change at 7-months post-TAVR is associated with LV mass regression and myocardial fibrosis

  up to 7-months post-TAVR

Study Arms (1)

Multimodality Imaging and Biomarkers

Post-TAVR patients who received commercial Medtronic Evolut-R or Evolut PRO bioprosthesis implant and found to have at least mild PVL on 1-month post-TAVR echocardiogram will undergo multimodality imaging and biomarkers evaluation at 1-month and 7-months post-TAVR.

Diagnostic Test: Multimodality Imaging and Biomarkers

Interventions

Multimodality Imaging and Biomarkers DIAGNOSTIC_TEST

Cardiac MRI, Cardiac MDCT, Echocardiography and Biomarkers Testing

Multimodality Imaging and Biomarkers

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

55 men and women aged 60 or above who received Medtronic Evolut-R or Evolut PRO and have at least mild paravalvular leak on transthoracic echocardiogram performed 25-45 days after TAVR procedure.

You may qualify if:

• 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 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (3)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Houston Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, G1V 4G5, Canada

Location

Biospecimen

Retention: NONE RETAINED

Samples for future

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: June 22, 2017
• Study Start: January 1, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)