Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
Study NCT ID:
NCT04151966
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2019-11-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Evaluation of Potential Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.
Detailed Description:
External transthoracic direct current (DC) cardioversion is a commonly used method of terminating cardiac arrhythmias. Conventional wisdom indicates that external DC cardioversion causes myocardial injury. Previous research has shown that DC cardioversion resulted in myocardial injury as evidenced by increased levels of cardiac troponin, even though those changes were modest. Many of these studies evaluated monophasic defibrillators and older, less sensitive cardiac troponin assays. The current standard is now to use modern biphasic defibrillators and new high sensitivity cardiac troponin assays (hs-cTnT). It is conceivable that the newer defibrillators may not cause myocardial injury. It would be important to understand if myocardial injury occurs in this setting and its approximate magnitude as it would the interpretation of hs-cTnT values in patients and therefore influenced diagnoses. It may be if a threshold energy level can be identified that is would also influence the choice of energy used to deliver the shock in this situation.
A previous preliminary study documented no evidence of myocardial injury after elective DC cardioversion with modern day defibrillators. We aim to validate and expand that study here at Mayo Clinic Rochester.
A previous preliminary study documented no evidence of myocardial injury after elective DC cardioversion with modern day defibrillators. We aim to validate and expand that study here at Mayo Clinic Rochester.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: