The primary objective of this study is to investigate the feasibility of iSuite to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-EP
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successful creation of an electroanatomical map of the heart based on which the
real-time location of the catheters can be correctly and reliably visualized
during CMR-EP.
Secondary outcome
- Procedural success as measured by electrical and anatomical confirmation of a
complete ablation lesion at the end of the procedure.
- Procedure-by-procedure change in procedural times and total amount of CMR
images made prior to the first ablation lesion.
- Periprocedural complication rate.
- Anatomical confirmation of chronic ablation lesion on the CMR at 3- and 12-
month follow-up.
Background summary
Electrophysiological (EP) study and radiofrequency catheter ablation is an
important treatment strategy for patients with symptomatic cardiac arrhythmias.
Historically, the catheter navigation during EP study is guided by fluoroscopy
and an electroanatomical mapping system (EAM). Currently, *zero fluoroscopy* EP
procedures are gaining popularity, with intracardiac echocardiography, use of
EAM-only and cardiac magnetic resonance imaging (CMR) as important imaging
tools to replace fluoroscopy. In a CMR-guided electrophysiological procedure
(CMR-EP), magnetic resonance imaging (MRI) offers real-time visualization of
the heart, the catheters and concurrent visualization of the neighbouring
(extra)cardiac structures. In addition, MRI is able to differentiate specific
tissue types and structures, both healthy and diseased, which can aid in the
diagnostic and therapeutic process. In the standard CMR-EP set-up the treating
electrophysiologist uses the anatomical and structural information from the
MRI-scanner and the electrical activity directly measured with the
MRI-compatible catheters to perform the procedure. However, an EAM that gathers
the electrical information to create an electroanatomical map and integrates
this map with the real-time MRI images is not yet commercially available. A
limited number of EAM systems have been developed for CMR-EP, amongst them the
Philips interventional MRI suite *iSuite* (henceforward called iSuite), which
is yet to be CE marked.
Study objective
The primary objective of this study is to investigate the feasibility of iSuite
to create an electroanatomical map of the heart based on which the real-time
location of the catheters can be correctly and reliably visualized during
CMR-EP
Study design
The study is designed as a prospective single-arm observational open*label
single center study.
Study burden and risks
This study will not delay any necessary treatment and the study is not expected
to adversely affect outcome. The use of iSuite during the standard CMR-EP is
expected to yield no additional risk for the patient.
When the patient gives informed consent to the additional MRI scans at 3- and
12-months follow-up, then a time investment of approximately two times 3 hours
(twice an MRI scan plus travel time). The exposure to electromagnetic radiation
during two additional MRI-scans post-ablation is expected to carry very low
risk.
P Debyelaan 25
Maastricht 6229 HX
NL
P Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Already scheduled by the treating electrophysiologist for CMR-EP as standard
care for the treatment of a cardiac arrhythmia.
- Minimum age of 18 years old.
- Written informed consent.
Exclusion criteria
- Participation in another investigational study that has not reached its
primary endpoint.
- Refusal of data storage until 15 years after end of study.
To be noted: All patients that are included in this study are already scheduled
and thus considered eligible for CMR-EP by the treating electrophysiologist. A
strict prerequisite for CMR-EP is that the patient has no contraindication for
MRI (metallic implant, body weight > 130 kg, pregnancy, breast feeding women,
known severe allergy to gadolineum contrast agents, renal failure with eGFR <=
30 mL/min/1,73m2) or contraindication for an EP procedure.
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 | NL74812.068.20 |