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| ID | Type | Description | Link |
|---|---|---|---|
| METC20-064 | Other Identifier | METC azM/UM |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marisevi Chaldoupi | Contact | +31 43 387 7223 | marisevi.chaldoupi@mumc.nl | |
| Miranda Bijvoet | Contact | +31 43 387 7223 | miranda.bijvoet@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| S.M. Chaldoupi | Maastricht UMC | Principal Investigator |
| Casper Mihl | Maastricht UMC | Principal Investigator |
| J.E Wildberger, Prof. Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC+ | Recruiting | Maastricht | Limburg | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26316146 | Background | 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. | |
| 30307544 |
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This is a small scale single center study and there is no plan to share IPD in order to ensure participant privacy, and the risk of invalid analysis. Data will be registered in the Castor EDC database by the investigator, after patient data has been anonymized. The principal investigator and involved investigators of the research team will have access to the source data and safeguard the code. The handling of personal data will comply with the General Data Protection Regulation and the Dutch Act on Implementation of the General Protection Regulation. Data and the key to the unique patient study number will be kept for 15 years after study end. During this single centre study, no data will be shared or transferred. Once the study has ended, we will ensure that all data are managed and securely stored. Data will be available for use in future research on cardiac arrhythmia. Qualified monitors of Clinical Trial Centre Maastricht will independently perform monitoring of the study.
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000075002 | Bestrophins |
| ID | Term |
|---|---|
| D018118 | Chloride Channels |
| D007473 | Ion Channels |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
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| Periprocedural |
| 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 |
| Complication rate | To investigate the complication rate of CMR-EP with the integration of iSuite. | Periprocedural |
| Maastricht UMC |
| Study Chair |
| 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. |
| 21034854 | 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. |
| 29878090 | 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. |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005136 | Eye Proteins |
| D008562 | Membrane Glycoproteins |
| D008565 | Membrane Proteins |