Clinical trial NCT04727645: Use of "iSuite" During CMR-guided Electrophysiological Procedures
Official title: Prospective Use of Philips "iSuite" Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmia
Keywords: Cardiac Magnetic Resonance Imaging (CMR)
CMR-guided electrophysiological procedure
Radiofrequency ablation
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all eligible patients who are already scheduled and thus eligible for CMR-guided electrophysiological procedure for the treatment of a cardiac rhythm disturbance in the MUMC+, albeit meeting the in- and exclusion criteria.

Brief summary: The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "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-guided electrophysiological procedure (CMR-EP).


Eligibility criteria: 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.
* Contraindication for MRI such as: 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.

Primary outcomes:
measure: The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP
timeFrame: Periprocedural
Secondary outcomes:
measure: Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure:
timeFrame: Periprocedural
measure: Procedural time
timeFrame: Periprocedural
measure: Complication rate
timeFrame: Periprocedural
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: S.M. Chaldoupi
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+
name: Casper Mihl
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht UMC+
name: J.E Wildberger, Prof. Dr
role: STUDY_CHAIR
References:
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citation: Paetsch I, Sommer P, Jahnke C, Hilbert S, Loebe S, Schoene K, Oebel S, Krueger S, Weiss S, Smink J, Lloyd T, Hindricks G. Clinical workflow and applicability of electrophysiological cardiovascular magnetic resonance-guided radiofrequency ablation of isthmus-dependent atrial flutter. Eur Heart J Cardiovasc Imaging. 2019 Feb 1;20(2):147-156. doi: 10.1093/ehjci/jey143.
citation: Vergara GR, Vijayakumar S, Kholmovski EG, Blauer JJ, Guttman MA, Gloschat C, Payne G, Vij K, Akoum NW, Daccarett M, McGann CJ, Macleod RS, Marrouche NF. Real-time magnetic resonance imaging-guided radiofrequency atrial ablation and visualization of lesion formation at 3 Tesla. Heart Rhythm. 2011 Feb;8(2):295-303. doi: 10.1016/j.hrthm.2010.10.032. Epub 2010 Oct 27.
citation: Lichter J, Kholmovski EG, Coulombe N, Ghafoori E, Kamali R, MacLeod R, Ranjan R. Real-time magnetic resonance imaging-guided cryoablation of the pulmonary veins with acute freeze-zone and chronic lesion assessment. Europace. 2019 Jan 1;21(1):154-162. doi: 10.1093/europace/euy089.