Use of "iSuite" During CMR-guided Electrophysiological Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2024-12-31

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).

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Detailed Description

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Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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"iSuite"

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No