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Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAGNET | Active Comparator | magnet application over cardiac device |
|
| REPROGRAMING | Active Comparator | reprograming of cardiac device by trained technician/electrophysiologist |
|
| NO ACTION | Active Comparator | no action is performed if patient meets inclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGNET APPLICATION | Device |
| ||
| REPROGRAMING |
| Measure | Description | Time Frame |
|---|---|---|
| Any inappropriate sensing of EMI caused by electrocautery. | DURING SURGERY/PROCEDURE |
| Measure | Description | Time Frame |
|---|---|---|
| Any significant change in CIEDS parameters | WITHIN 1 DAY OF SURGERY/PROCEDURE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MAHMOUD SULEIMAN, MD | Contact | 972502061385 | M_SULEIMAN@RAMBAM.HEALTH.GOV.IL |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Haifa | 31096 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21722856 | Background | Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available. |
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|
| NO ACTION | Device |
|