Use of "iSuite" During CMR-guided Electrophysiological Procedures

NCT04727645 | Unknown DMC

• 2 other identifiers: NL74812.068.20METC20-064
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Arrhythmia

Keywords

Cardiac Magnetic Resonance Imaging (CMR); CMR-guided electrophysiological procedure; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure:

  Periprocedural

• Procedural time

  Periprocedural

• Complication rate

  Periprocedural

Interventions

Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands) OTHER

iSuite is an an electroanatomical mapping system (EAM) designed to support real-time MRI guided interventional procedures.

Also known as: "iSuite"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 26316146 BACKGROUND

• 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.

  PMID: 30307544 BACKGROUND

• 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.

  PMID: 21034854 BACKGROUND

• 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.

  PMID: 29878090 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Bestrophins

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloride Channels; Ion Channels; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Eye Proteins; Membrane Glycoproteins; Membrane Proteins

Study Officials

• S.M. Chaldoupi

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

• Casper Mihl

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

• J.E Wildberger, Prof. Dr

  Maastricht UMC+

  STUDY CHAIR

Central Study Contacts

Marisevi Chaldoupi

CONTACT

+31 43 387 7223; marisevi.chaldoupi@mumc.nl

Miranda Bijvoet

CONTACT

+31 43 387 7223; miranda.bijvoet@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: January 4, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)