Trial Outcomes & Findings for Implantable Cardioverter-Defibrillator Use in the VA System (NCT NCT01217827)
NCT ID: NCT01217827
Last Updated: 2021-05-19
Results Overview
Referral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
89 participants
Primary outcome timeframe
6 months
Results posted on
2021-05-19
Participant Flow
Participant milestones
| Measure |
Clinical Reminder
Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder
|
Control
This group does not receive an intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
43
|
|
Overall Study
COMPLETED
|
46
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implantable Cardioverter-Defibrillator Use in the VA System
Baseline characteristics by cohort
| Measure |
Clinical Reminder
n=46 Participants
Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder
|
Control
n=43 Participants
This group does not receive an intervention.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8 • n=7 Participants
|
65 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
43 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsReferral of the patient to electrophysiology clinic for evaluation for cardioverter defibrillator implantation.
Outcome measures
| Measure |
Clinical Reminder
n=46 Participants
Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder
|
Control
n=43 Participants
This group does not receive an intervention.
|
|---|---|---|
|
Referral for Implantable Cardioverter Defibrillator
|
11 participants
|
1 participants
|
Adverse Events
Clinical Reminder
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinical Reminder
n=46 participants at risk
Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.
Clinical Reminder
|
Control
n=43 participants at risk
This group does not receive an intervention.
|
|---|---|---|
|
Cardiac disorders
Death
|
2.2%
1/46 • Number of events 1
|
9.3%
4/43 • Number of events 4
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place