Paravalvular Leak Clinical Trial
— Class-CMROfficial title:
Multicenter Prospective CoreValve Study Using Cardiac MRI for Assessment of Paravalvular Aortic Regurgitation and Its Impact on LV Reverse Remodeling and Cardiovascular Outcomes
Verified date | May 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | February 15, 2019 |
Est. primary completion date | February 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 100 Years |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Quebec | |
United States | Houston Methodist DeBakey Heart & Vascular Center | Houston | Texas |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PVL severity change at 7-months post-TAVR is associated with LV mass regression and myocardial fibrosis | To test that PVL severity change by CMR over 6-month period post-TAVR (comparing assessment at 1-month vs 7-months post-TAVR regurgitant fraction and regurgitant volume), is a determinant of LV reverse remodeling and negatively correlates with the regression of LV mass and myocardial fibrosis assessed by CMR. | up to 7-months post-TAVR | |
Primary | 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 | Intra- and inter-observer variability of PVL severity assessment | To test the hypothesis that PVL severity, assessed by CMR using regurgitant fraction and regurgitant volume, at both 1-month and 7-months post-TAVR has lower intra and inter-observer variability when compared to its assessment by TTE. | 1-month and 7-months post-TAVR |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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