Trial Outcomes & Findings for Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement (NCT NCT04206371)
NCT ID: NCT04206371
Last Updated: 2026-05-14
Results Overview
Abnormal shock impedance value.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
4 hours
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Defibrillation Testing During ICD Replacment
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock.
|
|---|---|
|
Procedure
STARTED
|
143
|
|
Procedure
COMPLETED
|
139
|
|
Procedure
NOT COMPLETED
|
4
|
|
12-Month Follow-up
STARTED
|
143
|
|
12-Month Follow-up
COMPLETED
|
133
|
|
12-Month Follow-up
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Defibrillation Testing During ICD Replacment
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock.
|
|---|---|
|
Procedure
Adverse Event
|
1
|
|
Procedure
Physician Decision
|
3
|
|
12-Month Follow-up
Lost to Follow-up
|
3
|
|
12-Month Follow-up
Adverse Event
|
4
|
|
12-Month Follow-up
Physician Decision
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Defibrillation Testing During ICD Replacment
n=143 Participants
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock.
|
|---|---|
|
Age, Continuous
|
69 years
n=143 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=143 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=143 Participants
|
|
IMC
|
27 kg/m2
n=143 Participants
|
PRIMARY outcome
Timeframe: 4 hoursAbnormal shock impedance value.
Outcome measures
| Measure |
Defibrillation Testing During ICD Replacment
n=139 Participants
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock.
|
|---|---|
|
Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement.
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsabnormal impedance value
Outcome measures
| Measure |
Defibrillation Testing During ICD Replacment
n=140 Participants
Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock.
|
|---|---|
|
Rate of Lead Malfunction
|
3 Participants
|
Adverse Events
Defibrillation Testing During ICD Replacment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place