Use of "iSuite" During CMR-guided Electrophysiological Procedures

Cardiac Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727645
• Other study ID #: NL74812.068.20
• Secondary ID: METC20-064
• Status: Recruiting
• Start date: January 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Academisch Ziekenhuis Maastricht
• Contact: Marisevi Chaldoupi
• Phone: +31 43 387 7223
• Email: marisevi.chaldoupi[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Complication rate	To investigate the complication rate of CMR-EP with the integration of iSuite.	Periprocedural