NCT04284800

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2020Dec 2026

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 7, 2025

Status Verified

July 1, 2025

Enrollment Period

5.5 years

First QC Date

February 24, 2020

Last Update Submit

July 3, 2025

Conditions

ICD

Keywords

Defibrillation Threshold Testing

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum or plasma samples remaining after initial analysis will be frozen and stored at -80 degrees Celsius for 120 months (10 years). These samples may be used if there are new and more sensitive biomarkers of myocardial injury that become available.

Study Officials

  • Allan S Jaffe, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)