Prospective Use of Philips "iSuite" Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP
Time Frame: Periprocedural
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).
Secondary Outcomes
- Procedural time(Periprocedural)
- Complication rate(Periprocedural)
- Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure:(Periprocedural)
Investigators
S.M. Chaldoupi
MD, PhD
Academisch Ziekenhuis Maastricht