ICDNCT04284800
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing
An observational study of ICD, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ICD
- Keywords
- Defibrillation Threshold Testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial injury
Changes in the high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
Measured: Baseline, approximately 6-24 hours after DFT procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICDStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan S. Jaffe, Mayo Clinic
- Investigators
- Allan S Jaffe, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284800
- Sponsor's protocol ID
- 19-008297
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2020
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Potential Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing
- ClinicalTrials.gov ID
- NCT04284800
- Acronym / sponsor ID
- 19-008297
- Conditions
- ICD
- Keywords
- Defibrillation Threshold Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial injury
Time frame: Baseline, approximately 6-24 hours after DFT procedure
Changes in the high sensitivity cardiac troponin T (hs-cTnT) or troponin I (hs-cTnI) assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan S Jaffe, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICD, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial injury (time frame: Baseline, approximately 6-24 hours after DFT procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.