The objective of this randomized controlled trial (RCT) is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide* (FHG)) adequately predicts procedural outcomes in TAVR procedures, whether it…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mild to severe PVR
Secondary outcome
New CD (new-onset left bundle branch block, new-onset atrioventricular block)
requiring permanent pacemaker (PPM) implantation.
Preoperative and final selected valve size, target and final implantation
depth, change of preoperative decision, failure to implant valve, MACCE
composite endpoint, quality of life, healthcare costs and cost-effectiveness,
FFR measurement (on standard MSCT and CAG).
Background summary
Combining routine preoperative CT imaging with patient-specific computer
modelling predicts the interaction between different sizes of transcatheter
aortic valve replacement (TAVR) devices at different implantation depths and
the patient*s unique anatomy (including post-implantation deformation) allowing
preoperative evaluation of the risk for paravalvular leakage (PVR) and
conduction disorders (CD).
Study objective
The objective of this randomized controlled trial (RCT) is to evaluate whether
pre-operative CT-imaging with advanced computer modelling and simulation (FEops
HEARTguide* (FHG)) adequately predicts procedural outcomes in TAVR procedures,
whether it leads to changes of preoperative decisions and whether or not this
leads to improved outcome in TAVR procedures and reduction in health care
costs.
Study design
Single center, randomized controlled, open-label, pilot trial.
Intervention
In patients randomized to arm 1, FEops HEARTGuide will be added to routine
preoperative CT imaging. Results of the computer modelling will be discussed
with TAVR implanting team prior to the procedure. Patients randomized to arm 2
will only have routine preoperative CT imaging.
Study burden and risks
FEops HEARTguide* is designed to predict the interaction between the TAVR
device and the patient*s unique anatomy, including post-implantation
deformation, allowing physicians to assess the risk for aortic regurgitation
and conduction abnormalities. Especially in patients with complex anatomy such
as BAV, it could be of great value to be able to predict the possible
complications in order to identify patients at risk for these unfavourable
outcomes. This additional information may improve the outcomes of the TAVR
patients included in the FHG arm of our study population.
Unfortunately, since FEops HEARTGuide is not on the market yet for the SAPIEN
transcatheter heartvalves (Edwards) and the PORTICO Valve (Abbott), the
patients that are chosen to be more suitable to one of these valves by the
physicians will have to be excluded. As a consequence, the findings of our
study will not be applicable for all current available TAVR valves.
The risks related to the use of FEops HEARTGuide for TAVR patients are
negligible, due to multiple reasons. First of all, the physician chooses the
optimal treatment on the basis of both simulation results and clinical aspects.
This means that FEops HEARTGuide does not give the *best option*, but only
simulates the valve type(s) picked by the physician in multiple sizes and for
multiple implantation depths per size. After FEops HEARTGuide has provided
these options to the physician, they will be evaluated by the physician and
valued as acceptable or not. Therefore, FEops HEARTGuide is an add-on to the
standard pre-procedural planning and not a replacement.
The only extra burden for each patient consists of the quality of life
questionnaires, which will take up up to 20 minutes for each patient.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Primary symptomatic severe aortic valve stenosis (defined as an aortic valve
area of <1.0cm2 and either a mean valve gradient of at least 40mmHg or a peak
velocity of at least 4.0 m/s)
- Accepted for TAVR, either by transfemoral, transsubclavian or transapical
access as determined by the Heart Team and additionally the dedicated TAVR-team.
- Plan to implant one of the following TAVR heart valves for which FEops
HEARTguide* is available:
o CoreValve*, Evolut* R, and Evolut* PRO and Evolut* PRO+ valves (Medtronic)
o ACURATE neo* Aortic Valve System (Boston Scientific) (ACURATE neo 2* will be
available for FHG later this year)
- Informed consent
Exclusion criteria
- Previous surgical aortic valve replacement
- Permanent pacemaker at baseline
- Emergency procedure
- Poor CT image quality (disabling computer-simulation), for example because of
motion artifacts due to the presence of other implanted devices affecting the
region of interest
- Patient who did not agree to the informed consent and/or refused to
participate
- Patient unable to understand the informed consent/study
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 | NL77697.100.21 |