Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02079129 |
| Other study ID # |
013-185 |
| Secondary ID |
PVL-TAVR |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
July 2018 |
Study information
| Verified date |
January 2020 |
| Source |
Baylor Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study objective is to assess the agreement between cMRI PVL grading (based on regurgitant
fraction) and TTE PVL grading (based on pressure half-time and the ratio of the jet arc to
the circumference of the annulus).
Description:
Background/Rationale
There are currently no objective, validated measures of paravalvular leak (PVL) by
echocardiogram (Lerakis et al). The PARTNER 2 year outcomes demonstrated that even mild PVL
is associated with poor prognosis (Kodali et al) and decreased survival after transaortic
valve replacement (TAVR). It has been proposed that the severity of PVL could be measured
based on a comparison of jet arc length and pressure half-time on color Doppler transthoracic
echocardiogram (TTE) to the circumference of the valve annulus in the parasternal short-axis
view. Accordingly, a jet arc corresponding to <10% of the annulus circumference indicates
mild PVL, 10-20% moderate PVL, and >20% severe PVL. However, this grading method still needs
to be validated against an independent reference standard such as Cardiac MRI (cMRI).
Cardiac MRI (cMRI) is a reliable way to measure PVL post-TAVR. It enables measurement of both
regurgitant volume and regurgitant fraction using gradient echo-based phase-contrast sequence
velocity flow mapping, accurately measuring forward stroke volume and backward regurgitant
flow across the valve. Being independent of jet morphology, cMRI may be a superior way to
follow patients post-TAVR. cMRI provides a quantitative assessment of the regurgitant
fraction and can therefore serve as the reference standard for validation of TTE-based
grading schemes.
Study Procedures
Patients seen at The Heart Hospital Baylor Plano (THHBP) will be enrolled into the study if
they are eligible and provide written consent. Upon enrollment, demographic and clinical risk
factors data will be collected for each patient. All patients will receive TTE and cMRI,
within 1 week of each other, at their 30 days ± 14 days, 6 months ± 30 days, or 1 year ± 60
days follow up visit post-TAVR. TTE is usually performed at these follow-up visits as part of
the routine clinical work up. All females of childbearing age will have a urine pregnancy
test prior to cMRI. Patients will be assigned PVL severity grades according to the two
diagnostic methods by Dr. Grayburn (TTEs), and Dr. Gopal (cMRIs). Both investigators will be
blinded to each other grading results.
Risk/Benefit
MRI does not use ionizing radiation (high-energy radiation that can potentially cause damage
to DNA, like the x-rays used CT scans).
There are no known harmful side-effects associated with temporary exposure to the strong
magnetic field used by MRI scanners. However, there are important safety concerns to consider
before performing or undergoing an MRI scan (U.S. Food and Drug Administration):
- The magnet may cause pacemakers, artificial limbs, and other implanted medical devices
that contain metal to malfunction or heat up during the exam.
- Any loose metal object may cause damage or injury if it gets pulled toward the magnet.
- If a contrast agent is used, there is a slight risk of an allergic reaction. MRI
contrast agents can cause problems in patients with significant kidney disease.
- Dyes from tattoos or tattooed eyeliner can cause skin or eye irritation.
- Medication patches can cause a skin burn.
- The wire leads used to monitor an electrocardiogram (ECG) trace or respiration during a
scan must be placed carefully to avoid causing a skin burn.
- Prolonged exposure to radio waves during the scan could lead to slight warming of the
body.
There are no known risks from a TTE. During this procedure, a technician obtains views of the
heart by moving a transducer to different locations on the chest or abdominal wall. The
transducer sends sound waves into the chest and picks up echoes that reflect off different
parts of the heart (Cleveland Clinic).
Minimization of Risk
Patient safety during this study will be the highest priority. All diagnostic
tests/treatments provided are commonly accepted and FDA approved. These test/treatments would
be provided as part of the patients' post-operative follow up and the patients will not incur
any additional health risks as subjects in this study. The patients will not incur any
psychological, social, legal or economic risks by participating in this study.
Benefits
Subjects will not directly benefit from this research. The results of this study may provide
important information for the medical imaging options for future valve replacement patients.
Adverse Events
Adverse Events (AEs) for purposes of this trial will include AEs related to TTE or MRI.
