Use of iSuite During CMR-guided Electrophysiological Procedures

Study Overview
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Brief Summary
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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).

Official Title
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Prospective Use of Philips iSuite Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Other: Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)|iSuite is an an electroanatomical mapping system (EAM) designed to support real-time MRI guided interventional procedures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP | To establish whether the visualization by iSuite is correct we will compare the location visualized by the EAM with the reference images as produced by the default cine MRI sequences at the target ablation location just prior to the RF ablation. The definition of correct visualization is: good agreement between the two modalities (EAM and cine MRI) based on visual assessment of the treating electrophysiologist and the supervising CMR expert. When no consensus is reached than the visualization is coded 'incorrect'. This outcome will be dichotomized and coded as 'correct visualization' or 'incorrect visualization'. This categorical variable will be expressed as counts and proportion with 95% confidence interval (CI). | Periprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure: | Anatomical confirmation of a complete ablation lesion is defined as a continuous line of high signal intensity at the target location on the edema and fibrosis sequences of the CMR at the end of the procedure. This anatomical confirmation will be judged by the CMR expert that is present during the procedure and thus will not be blinded to the EP results. Procedural success and procedural complications will be reported as count and proportion with 95% CI. | Periprocedural | 
| Procedural time | To investigate the procedure-by-procedure change in procedural times and total amount of CMR images needed until application of the first ablation lesion | Periprocedural | 
| Complication rate | To investigate the complication rate of CMR-EP with the integration of iSuite. | Periprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Magnetic Resonance Imaging (CMR), CMR-guided electrophysiological procedure, Radiofrequency ablation