To study the technical performance and safety of the CARTBox-CA software for identification of scar-related substrate in patients. Secondary, to explore the usability of image-guided scar-related substrate mapping using CARTBox-CA software with a…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To explore the technical performance and safety of scar-related VT ablation
using CARTBox-CA platform in patients.
* Technical performance will be determined by assessing the relation between
the local surface mapping parameters and the local substrate parameters from
imaging.
* Safety will be established by evaluating (serious) adverse events related to
the use of CARTBox-CA.
Secondary outcome
To explore usability of image-guided scar-related substrate mapping using
CARTBox-CA software with a questionnaire.
Background summary
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder.
Currently, scar-related ablation targets are defined with substrate mapping.
Due to the inaccurate delineation of arrhythmogenic substrate around intramural
scars this leads to a high percentage of re-do procedures. Image integration
enables the visualization of the substrate as assessed by MRI or CT imaging in
conjunction with the substrate mapping technique. This may have important
diagnostic and therapeutic benefits to identify scars that could not be
identified by substrate mapping. The main aim of this pilot clinical study is
to investigate the technical performance and safety of scar-related VT ablation
procedures guided by CARTBox-CA software.
Study objective
To study the technical performance and safety of the CARTBox-CA software for
identification of scar-related substrate in patients. Secondary, to explore the
usability of image-guided scar-related substrate mapping using CARTBox-CA
software with a user questionnaire.
Study design
A multicentre, proof of concept, pilot study. All patients with scar-related
VT, meeting the inclusion criteria, will be considered for inclusion. The novel
CARTBox-CA Tool will be validated for evaluation of technical performance and
safety in clinical practice.
Intervention
VT RF ablation with support from CARTBox-CA image integration. CARTBox-CA
integrates 3D imaging models including scar-related regions in
electro-anatomical mapping.
Study burden and risks
During the ablation procedure in the Inventa-I study, landmark mapping and
additional substrate mapping is required for the registration and validation of
the imaging-defined scar regions during the ablation procedure respectively.
The extra mapping might increase the ablation procedure time with approximately
5 to 10 minutes. Because the landmark mapping and additional substrate mapping
can be done without using fluoroscopy, the extra radiation burden for the
patients in the Inventa-I study is negligible. Both the landmark mapping and
additional substrate mapping might improve the procedure because the imaging
defined scar is accurately visualized and the VT substrate is assessed with
highest possible detail. Both possibly resulting in a shorter and more
successful clinical intervention.
Padualaan 8
Utrecht 3584 CH
NL
Padualaan 8
Utrecht 3584 CH
NL
Listed location countries
Age
Inclusion criteria
- Patient must be willing and able to provide written informed consent
- Patient must be >= 18 years old
- Patient must have an indication for endocardial VT ablation according to the
European Society of Cardiology Guidelines for VT
- Presence of a ischemic heart disease
Exclusion criteria
- Contraindications for VT ablation (for example evidence of cardiac thrombi)
- Patients with idiopathic VT.
- Contraindications to both MRI and MDCT imaging:
- MRI: determined using the standard contraindications for MRI as
used for clinical purposes,
documented allergic reaction to gadolinium.
- MDCT: subjects with impaired renal function (severe renal
insufficiency, MDRD GFR of < 30
ml/min/1.73m2).
- Established atrial fibrillation during MRI or CT
- Patients must not be pregnant or lactating
- Participation in another clinical study that prohibits any procedures other
than standard
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 | NL78490.000.21 |