The purpose of the study is to compare parameters of 4D flow derived non-invasive PV-loop to invasively derived intracardiac pressure recording.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main trial endpoints include maximum pressure, (mmHg), minimum pressure,
(mmHg), end-systolic volume, (mL), and end-diastolic volume, (mL). Secondary
endpoints include stroke volume, (mL), stroke work, (J), pressure-volume area,
(J), ejection fraction, (%), isovolumic relaxation constant (Tau), (ms),
end-systolic pressure volume relationship, (mmHg/mL), and end-diastolic
pressure volume relationship, (mmHg/mL).
Secondary outcome
Not applicable
Background summary
Hemodynamic evaluation using pressure-volume (PV) loops is crucial for
understanding cardiac function and diagnosing pathology, however it is reliant
on invasive catheterization. Promising non-invasive alternatives such as
four-dimensional cardiovascular magnetic resonance flow imaging (4D flow MRI)
and computational fluid dynamics (CFD) offer comprehensive visualization and
analysis of blood flow dynamics. By combining these techniques, it's possible
to estimate PV-loops non-invasively, showing promising results and potentially
reduce the need for invasive catheterization.
Study objective
The purpose of the study is to compare parameters of 4D flow derived
non-invasive PV-loop to invasively derived intracardiac pressure recording.
Study design
A prospective non-randomized single group observational study, where subjects
who are scheduled for invasive cardiac catheterization will undergo a pressure
recording in the left ventricle, as well as a 4D flow cardiac MRI examination
on the same day or within one week before or after the invasive
catheterization. During the cardiac catheterization procedure, an additional
pressure wire will be introduced in the left ventricle cavity by using an
ultrathin, flexible pressure catheter (OptoWire III Pressure Guidewire, Opsens
Inc., Québec, Canada). Additionally, patients will also undergo intracardiac 4D
flow MRI within one week before or after the invasive procedure. Parameters
from the PV-loops between the two methods will be compared to determine the
validity of the non-invasive PV-loops.
Study burden and risks
The study includes patients that will already undergo invasive cardiac
catheterization. The only additional procedure required, is positioning of the
ultrathin pressure catheter through the aortic valve into the left ventricle
cavity. This is only associated with a minor risk of arrythmias, which are
typically transient. During the procedure the patient is closely monitored. The
4D flow MRI examination does not add any increased risks for the patient given
the fact that no gadolinium is used. Both procedures facilitate the potential
clinical validation of non-invasive PV-loops, and would benefit the overall
population by minimizing the need for invasive cardiac function assessment in
the future.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Aged 18 years or older.
Will undergo invasive cardiac catheterization for clinically indicated reasons.
Eligible for undergoing an MRI examination.
Exclusion criteria
Contraindications for undergoing an MRI examination (e.g. non-compatible MR
material or devices).
Moderate or severe aortic valve stenosis.
Left ventricle outflow tract obstruction.
Prosthetic aortic valve.
Design
Recruitment
Medical products/devices used
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 | NL86844.100.24 |