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Clinical Trials/NCT04151966
NCT04151966
Completed
Not Applicable

Evaluation of Potential Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias

Mayo Clinic1 site in 1 country104 target enrollmentJuly 22, 2019
ConditionsCardioversion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardioversion
Sponsor
Mayo Clinic
Enrollment
104
Locations
1
Primary Endpoint
Myocardial injury
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 22, 2019
End Date
December 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allan S. Jaffe

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Patients who are undergoing elective direct current cardioversion, either externally or via the patient's internal cardioverter-defibrillator

Exclusion Criteria

  • Patients under age 18
  • Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
  • Pregnant patients
  • Patients who cannot provide informed consent because of cognitive dysfunction

Outcomes

Primary Outcomes

Myocardial injury

Time Frame: Baseline, 6-24 hours post procedure

Changes in high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay

Study Sites (1)

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