Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing

Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing

Researchers are trying to determine if heart injury occurs in patients with a cardiac implantable electronic device (CIED) who undergo a defibrillation threshold testing (DFT) procedure.

Study Overview

• Status: Active, not recruiting
• Conditions: ICD

Detailed Description

CIED devices that deliver defibrillation can provide life-saving therapy to patients who have cardiac conditions that make them prone to develop a serious arrhythmia. Currently, there are two main CIED devices that deliver defibrillation therapy - transvenous internal cardioverter-defibrillator (ICD) and subcutaneous ICD. Conventional wisdom indicates that defibrillation causes myocardial injury. However, some studies including one by the present investigators have reported that external direct current cardioversion does not result in myocardial injury. There have been studies showing that ICD shocks results in myocardial injury. The concern with previous studies using transvenous ICDs is that the measurement of injury was done during DFT testing at the time of ICD implantation or when the patient came into hospital after an ICD shock. The confounder with DFT testing is that myocardial injury could have occurred during ICD implantation when the lead is screwed into the myocardium rather than during the testing. With hospitalization, the precipitating event that caused the arrhythmia stimulating the ICD discharge (e.g. an acute coronary syndrome) might also be the cause of myocardial injury. We plan to eliminate these confounders by recruiting patients who are undergoing a DFT procedure electively, remote from their ICD implantation date or clinical events.

In terms of the subcutaneous ICD implantation (in which the leads are not screwed into the myocardium), there is little data about myocardial injury when a shock is delivered. The investigators will attempt to determine if subcutaneous ICD shocks cause myocardial injury by assessing their troponin levels at the time DFT is performed during implantation.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult males and females age 18 and above who have a cardiac implantable electronic device (CIED) or about to receive a CIED, and scheduled to undergo a defibrillation threshold testing (DFT).

Description

Inclusion Criteria:

• Patients who are undergoing elective defibrillation threshold testing of their transvenous ICD or defibrillation threshold testing of the subcutaneous ICD at the time of implantation

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury	Changes in the high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay	Baseline, approximately 6-24 hours after DFT procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Allan S Jaffe, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Defibrillation Threshold Testing
• Other Study ID Numbers: 19-008297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No