Trial Outcomes & Findings for Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation (NCT NCT02111993)
NCT ID: NCT02111993
Last Updated: 2019-05-22
Results Overview
Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
20 hours (hr)
Results posted on
2019-05-22
Participant Flow
60 patients were consented and enrolled in this trial. 9 of which were withdrawn due to incomplete lab draws. 51 patients successfully completed study procedures and were included in the study data analysis.
Participant milestones
| Measure |
Standard Defibrillation Testing
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Standard Defibrillation Testing
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
4
|
Baseline Characteristics
Evaluating Myocardial Injury for Defibrillation Threshold Testing Methods for ICD Implantation
Baseline characteristics by cohort
| Measure |
Standard Defibrillation Testing
n=25 Participants
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
n=26 Participants
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 16 • n=93 Participants
|
63 years
STANDARD_DEVIATION 11 • n=4 Participants
|
65 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
26 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
28.2 kg/m^2
STANDARD_DEVIATION 7.0 • n=93 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=4 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.1 • n=27 Participants
|
|
History of Hypertension (HTN)
|
16 participants
n=93 Participants
|
12 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Presence of Left Ventricular Hypertrophy (LVH)
|
9 participants
n=93 Participants
|
17 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
History of Ventricular Tachycardia (VT)
|
8 participants
n=93 Participants
|
10 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
History of Non-Ischemic Cardiomyopathy (NICM)
|
2 participants
n=93 Participants
|
6 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
History of Diabetes Mellitus (DM)
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
History of Coronary Artery Bypass Graft (CABG)
|
4 participants
n=93 Participants
|
1 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Secondary Prevention Implanted Cardiac Defibrillator (ICD)
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Anti-Arrhythmic Medication
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Beta-Blocker Medication
|
15 participants
n=93 Participants
|
19 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Ejection Fraction (EF) (%)
|
40 percentage
STANDARD_DEVIATION 17 • n=93 Participants
|
34 percentage
STANDARD_DEVIATION 18 • n=4 Participants
|
38 percentage
STANDARD_DEVIATION 17.6 • n=27 Participants
|
|
End Diastolic Volume (EDV)
|
5.4 cm
STANDARD_DEVIATION 0.9 • n=93 Participants
|
5.5 cm
STANDARD_DEVIATION 1.1 • n=4 Participants
|
5.45 cm
STANDARD_DEVIATION 1.0 • n=27 Participants
|
|
Dual Coil ICD
|
12 participants
n=93 Participants
|
10 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Single Coil ICD
|
13 participants
n=93 Participants
|
10 participants
n=4 Participants
|
23 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 20 hours (hr)Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.
Outcome measures
| Measure |
Standard Defibrillation Testing
n=25 Participants
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
n=26 Participants
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
|---|---|---|
|
Myocardial Damage
Δ4 hr cTnT
|
0.001 ng/mL
Standard Deviation 0.023
|
0.011 ng/mL
Standard Deviation 0.066
|
|
Myocardial Damage
Δ8 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.030
|
0.012 ng/mL
Standard Deviation 0.072
|
|
Myocardial Damage
Δ20 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.032
|
0.001 ng/mL
Standard Deviation 0.048
|
SECONDARY outcome
Timeframe: 20 hours (hr)the DFT group cardiac troponin (cTNT) values were compared to the subjects within the ULV group that required VF induction.
Outcome measures
| Measure |
Standard Defibrillation Testing
n=25 Participants
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
n=11 Participants
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
|---|---|---|
|
Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
Δ20 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.032
|
0.042 ng/mL
Standard Deviation 0.057
|
|
Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
Δ4 hr cTnT
|
0.001 ng/mL
Standard Deviation 0.023
|
0.075 ng/mL
Standard Deviation 0.086
|
|
Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)
Δ8 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.030
|
0.078 ng/mL
Standard Deviation 0.093
|
SECONDARY outcome
Timeframe: 20 hours (hr)The DFT group was compared to the ULV subgroup that did not require ventricular fibrillation (VF) induction. Cardiac troponin (cTNT) levels were analyzed.
Outcome measures
| Measure |
Standard Defibrillation Testing
n=25 Participants
Standard Defibrillation Threshold Testing is a procedure in which a low energy shock will be delivered to the heart to induce ventricular fibrillation (VF) followed by a rescue shock to restore sinus rhythm. Process is repeated after 5 minutes.
Standard Defibrillation Testing: Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
|
Upper Limit of VulnerabilityTesting
n=14 Participants
Upper Limit of Vulnerability Testing is a procedure in which four 18J shocks will be delivered at specified intervals. If VF is induced, then a 25 J rescue shock will be delivered.
Upper Limit of Vulnerability Testing: Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
|
|---|---|---|
|
Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
Δ4 hr cTnT
|
0.001 ng/mL
Standard Deviation 0.023
|
0.031 ng/mL
Standard Deviation 0.031
|
|
Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
Δ8 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.030
|
0.038 ng/mL
Standard Deviation 0.038
|
|
Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)
Δ20 hr cTnT
|
0.002 ng/mL
Standard Deviation 0.032
|
0.031 ng/mL
Standard Deviation 0.031
|
Adverse Events
Standard Defibrillation Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Upper Limit of VulnerabilityTesting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ulrika Birgersdotter-Green, MD
UC San Diego School of Medicine
Phone: 858-657-5310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place