Use of "iSuite" During CMR-guided Electrophysiological Procedures

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Other: Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Marisevi Chaldoupi; Phone Number: +31 43 387 7223; Email: marisevi.chaldoupi@mumc.nl
• Study Contact Backup: Name: Miranda Bijvoet; Phone Number: +31 43 387 7223; Email: miranda.bijvoet@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Recruiting
      • Maastricht UMC+
      • Sub-Investigator: K Vernooy, Prof. dr.
      • Sub-Investigator: G.P Bijvoet, MD
      • Sub-Investigator: R.J Holtackers, Ir
      • Sub-Investigator: S.J.M. van Kuijk, MD, PhD
      • Sub-Investigator: J.E Wildberger, Prof. dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Ziekenhuis Maastricht
• Investigators: Principal Investigator: S.M. Chaldoupi, Maastricht UMC+; Principal Investigator: Casper Mihl, Maastricht UMC+; Study Chair: J.E Wildberger, Prof. Dr, Maastricht UMC+

Publications and helpful links

General Publications

• Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.
• 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.
• Harrison J WS, Krueger S, Koken P, O'Neill M, Schaeffter T, Razavi R. Real-time magnetic resonance-guided radiofrequency atrial ablation: visualization of lesion formation and activation mapping. Heart Rhythm. 2013;10.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency ablation; Cardiac Magnetic Resonance Imaging (CMR); CMR-guided electrophysiological procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: NL74812.068.20; METC20-064 (Other Identifier: METC azM/UM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a small scale single center study and there is no plan to share IPD in order to ensure participant privacy, and the risk of invalid analysis. Data will be registered in the Castor EDC database by the investigator, after patient data has been anonymized. The principal investigator and involved investigators of the research team will have access to the source data and safeguard the code. The handling of personal data will comply with the General Data Protection Regulation and the Dutch Act on Implementation of the General Protection Regulation. Data and the key to the unique patient study number will be kept for 15 years after study end. During this single centre study, no data will be shared or transferred. Once the study has ended, we will ensure that all data are managed and securely stored. Data will be available for use in future research on cardiac arrhythmia. Qualified monitors of Clinical Trial Centre Maastricht will independently perform monitoring of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No