The INVA-SOUND-MRI (INVAsive, ultraSOUND and MRI assessment of transvalvular gradients after transcatheter aortic valve implantation) study aims to elucidate: 1) The accuracy of transaortic gradient assessment with different modalities (invasive,…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the transprosthetic aortic gradient by 4D flow
MRI.
Secondary outcome
Echocardiography derived:
• Mean aortic pressure gradient (PG) (mmHg)
• Peak aortic pressure gradient (PG) (mmHg)
• Peak aortic velocity (m/s)
Invasive:
• Mean aortic pressure gradient (PG) (mmHg)
• Peak aortic pressure gradient (PG) (mmHg)
• Peak aortic velocity (m/s)
4D Flow MRI derived:
• Peak aortic pressure gradient (PG) (mmHg)
• Peak aortic velocity (m/s)
• Wall shear stress (Pa)
• Energy loss (mW)
• Flow eccentricity
• LV ejection fraction (%)
• LV enddiastolic volume (ml)
• LV endsystolic volume (ml)
• LV stroke volume (ml)
• Ascending aortic diameter (mm)
For all included patients, baseline (medical) details will also be obtained
from patient records including age, sex, body mass index (BMI), relevant
medical history (including chronic obstructive pulmonary disease, asthma,
kidney failure, any previous malignancy, hypertension, diabetes mellitus,
hypercholesterolemia, cerebrovascular accident or transient ischemic attack,
any pre-existing supraventricular or ventricular rhythm disturbances,
assessment of valvulopathy, myocardial infarction or coronary artery bypass
graft and NYHA class of functional impairment. Kidney (dys)function prior to
the intervention will be graded according to the 2005 KDIGO guidelines.
Results of routine laboratory testing prior to the scheduled intervention will
be evaluated for all patients, including haemoglobin (mmol L-1), creatinine
level (µmol L-1), estimated glomerular filtration rate (e-GFR, ml min-1), high
sensitive troponin-T (ng L-1), C-reactive protein (CRP, mg L-1) and leucocyte
count (109 L-1).
Background summary
There is renewed interest in the evaluation of hemodynamic transcatheter aortic
valve performance with different imaging modalities. Recent studies suggest
that there is a discrepancy in transaortic pressure recordings between invasive
and ultrasound techniques. Notably, these discrepancies seem more pronounced
with balloon expandable than self-expanding supra-annular functioning
transcatheter aortic heart valves. The impact of the pressure recovery
phenomenon and intrinsic limitations of the ultrasound derived continuity
equation may explain these differences but the scientific underpinning is
limited. 4D flow Magnetic Resonance Imaging (MRI) can visualize blood flow
patterns and can be used to further elucidate these differences.
Study objective
The INVA-SOUND-MRI (INVAsive, ultraSOUND and MRI assessment of transvalvular
gradients after transcatheter aortic valve implantation) study aims to
elucidate:
1) The accuracy of transaortic gradient assessment with different modalities
(invasive, echocardiography). By comparing invasive and echo gradients to 4D
flow MRI-derived gradients, this may enhance the understanding of heart valve
performance after transcatheter aortic valve implantation (TAVI); 2) Different
patterns of transaortic pressure gradient recordings after TAVI with different
commercially available transcatheter heart valve platforms.
The primary objective of this study is to measure the transprosthetic aortic
gradient by 4D flow MRI after TAVI with a balloon expandable or self-expanding
transcatheter heart valve. These gradient measurements will then be compared to
both invasive and echocardiography-derived transvalvular gradient (these are
secondary objectives).
Study design
This study concerns a single-center, prospective, observational study which
will be conducted by the department of Cardiology and department of Radiology
and Nuclear Medicine. The primary objective of this study is to measure the
transprosthetic aortic gradient by 4D flow MRI in patients who recently
received a TAVI using either a balloon expandable or self-expanding
transcatheter heart valve. These gradient measurements will then be compared to
both invasive and echocardiography-derived transvalvular gradients. In addition
to comparing the gradient with different modalities (MRI, invasive, ultrasound)
within the same patient, the above parameters are also compared between 2
groups: the patients with balloon expandable versus the patients with
self-expanding transcatheter heart valve. Both groups will consist of 32
patients. After the MRI scan, there is no further follow-up as part of the
study. Acquisition of echocardiography-derived and invasive hemodynamic
measurements are standard clinical practice.
Intervention
The intervention involves a 4D flow MRI scan in which intravenous gadolinium
contrast is administered (0.2 mmol/kg).
Study burden and risks
Participating in the INVA-SOUND-MRI study does not offer any benefit to the
included patient. The risks and burden directly attributable to study
participation are considered low. Potential complications are directly
attributable to the MRI examination and gadolinium based contrast admission.
All invasive measurements during TAVI procedure as well as transthoracic
echocardiography exams are considered standard of care.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Adult patient (>18 years)
- Post TAVI procedure
- Successful TAVI with no unresolved procedure related complications (VARC-3
definition)
o Successful access, delivery of the device, and retrieval of the delivery
system
o Correct positioning of a single prosthetic heart valve into the proper
anatomical location
o Freedom from surgery or intervention related to the device or to a major
vascular or access-related, or cardiac structural complication
Exclusion criteria
- Age < 18 years
- Atrial fibrillation or atrial flutter or frequent extrasystole limiting the
quality of the cardiac MRI
- ICD or (temporary) pacemaker in situ
- Valve in valve procedure
- Claustrophobia
- Kidney injury (eGFR <30 mL/min per 1.73 m2)
- Gadolinium based contrast allergy
- No (written) informed consent was obtained
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86024.078.24 |