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Prospective use of Philips *iSuite* electroanatomical mapping system in addition to standard CMR-guided electrophysiological procedures.

Prospective use of Philips *iSuite* electroanatomical mapping system in addition to standard CMR-guided electrophysiological procedures. - Use of "iSuite" during CMR-guided electrophysiological procedures.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54396
Enrollment
100
Registered
2020-11-12
Start date
2021-02-22
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac arrhythmia

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Participation in another investigational study that has not reached its primary endpoint. - Refusal of data storage until 15 years after end of study. To be noted: All patients that are included in this study are already scheduled and thus considered eligible for CMR-EP by the treating electrophysiologist. A strict prerequisite for CMR-EP is that the patient has no contraindication for MRI (metallic implant, body weight > 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with eGFR

Design outcomes

Primary

MeasureTime frame
Successful creation of an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-EP.

Secondary

MeasureTime frame
- Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure. - Procedure-by-procedure change in procedural times and total amount of CMR images made prior to the first ablation lesion. - Periprocedural complication rate. - Anatomical confirmation of chronic ablation lesion on the CMR at 3- and 12- month follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026