Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556667
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
MAX - SHOCK Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Maximum Energy Shocks from Two Defibrillator Vendors MAX - SHOCK- a Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAX-SHOCK
Brief Summary:
Can Electrical Cardioversion ECV for AF be improved It is the preferred method to restore sinus rhythm in patients with AF in whom a rhythm-control strategy is pursued
Hypothesis
ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J Physio-Control compared to a biphasic defibrillator with maximum energy of 200J Zoll
Hypothesis
ECV success rates will be greater with a biphasic defibrillator with maximum energy of 360J Physio-Control compared to a biphasic defibrillator with maximum energy of 200J Zoll
Detailed Description:
Published estimates of ECV success using modern biphasic defibrillators vary considerably but most are limited by small sample sizes Our pre-intervention ECV success rate of 918 was stable over 25 years and is comparable to a previous study from our institute11 and to recent estimates from moderately sized studies using contemporary technology For instance the Euro Heart Survey on AF reported an ECV success rate of 91 in 424 patients2 and the Biphasic Energy Selection for Transthoracic cardioversion of Atrial Fibrillation BEST AF trial reported 89 success in 380 patients3 The variability in starting shock energy and shock energy escalation observed at our centre prior to implementing the OAFCP is also consistent with reported practices elsewhere A recent survey of 57 European centres found that nearly two-thirds of hospitals started with a 100 J biphasic shock for AF whereas the remaining third started with 200 J1 Considerable differences in electrode placement were also reported in this survey with 587 of centres using an anterolateral position and the remainder using an anteroposterior approach1Our investigators and others have previously shown that physicians seldom apply sufficient force even when prompted to do so and even when using handheld paddles101617 ECV practices at our institute prior to implementing the OAFCP were therefore likely representative of those at most centres
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None