N/A
Completed N=60
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
Cardiomyopathy · Heart Failure · Cardiac Arrhythmia
Source: ClinicalTrials.gov NCT02111993 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Myocardial Damage — 0.001; 0.011; 0.002; 0.012 ng/mL — p=0.02
Summary
The objective of this study is to evaluate myocardial injury, if any, as quantified by cardiac markers (Troponin-T) in defibrillation threshold (DFT) testing during implantation of implantable cardioverter defibrillators (ICDs) using the upper limit of vulnerability (ULV) method vs. standard defibrillation threshold method.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Damage |
0.001; 0.011; 0.002; 0.012; 0.002; 0.001 | 0.02 sig |
| SECONDARY Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced) |
0.001; 0.075; 0.002; 0.078; 0.002; 0.042 | 0.04 sig |
| SECONDARY Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced) |
0.001; 0.031; 0.002; 0.038; 0.002; 0.031 | 0.17 |
Eligibility Criteria
Inclusion Criteria
- Patients eligible to receive an ICD implant or change out.
- Patients with a single or dual coil right ventricle (RV) defibrillation lead located in the RV apex.
- Patients greater than 18 years of age.
- Patients willing and able to give informed consent.
- Patients who have insurance which may cover additional hospital stay if myocardial injury resulted from testing
Exclusion Criteria
- Patients with medical conditions that would limit study participation.
- Patients that are pregnant
Data sourced from ClinicalTrials.gov (NCT02111993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.