Trial Outcomes & Findings for Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation (NCT NCT04208997)
NCT ID: NCT04208997
Last Updated: 2022-11-14
Results Overview
A composite of all-cause mortality and VT recurrence one year after index VT ablation
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
5 participants
Primary outcome timeframe
One year after ablation
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Continuation of Antiarrhythmic Drugs
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation
Baseline characteristics by cohort
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
n=5 Participants
|
69.1 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Cardiomyopathy type
Ischemic cardiomyopathy
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cardiomyopathy type
Dilated cardiomyopathy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
25 %
n=5 Participants
|
42.5 %
n=7 Participants
|
30 %
n=5 Participants
|
PRIMARY outcome
Timeframe: One year after ablationA composite of all-cause mortality and VT recurrence one year after index VT ablation
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Number of Participants Dead or With VT Recurrence at One Year
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One year after ablationDeaths by any cause one year after ablation
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
All-cause Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One year after ablationSelf-terminating sustained VTs (\>30 seconds or hemodynamic instability) and VT requiring ICD device therapies for termination (appropriate therapies) will be considered VT recurrences
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Number of Participants With VT Recurrence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One year after ablationThree or more episodes of sustained VT, ventricular fibrillation, or appropriate ICD therapies within a 24-hour period
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Number of Participants With VT/Electrical Storm
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One year after ablationAdmissions with heart failure as principal diagnosis
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=1 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Number of Participants With Readmission for Heart Failure
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year after ablationSide effects attributed to any drug of the patient's regimen
Outcome measures
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 Participants
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 Participants
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Number of Participants With Drug Side Effects
|
1 Participants
|
0 Participants
|
Adverse Events
Continuation of Antiarrhythmic Drugs
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Discontinuation of Antiarrhythmic Drugs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Continuation of Antiarrhythmic Drugs
n=3 participants at risk
Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.
Antiarrhythmic drug: Continuation of amiodarone or sotalol.
|
Discontinuation of Antiarrhythmic Drugs
n=2 participants at risk
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
|
|---|---|---|
|
Nervous system disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 1 year
Chart review
|
0.00%
0/2 • 1 year
Chart review
|
Additional Information
Dr Giovanni Davogustto
Vanderbilt University Medical Center
Phone: 6159361720
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place