Trial Outcomes & Findings for ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy (NCT NCT00147277)
NCT ID: NCT00147277
Last Updated: 2025-07-11
Results Overview
Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
COMPLETED
PHASE4
925 participants
one year
2025-07-11
Participant Flow
Participant milestones
| Measure |
8 Pulses Anti-Tachycardia Pacing (ATP)
8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
15 Pulses Anti-Tachycardia Pacing (ATP)
15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
|---|---|---|
|
Overall Study
STARTED
|
475
|
450
|
|
Overall Study
COMPLETED
|
475
|
450
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Baseline characteristics by cohort
| Measure |
8 Pulses Anti-Tachycardia Pacing (ATP)
n=475 Participants
8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
15 Pulses Anti-Tachycardia Pacing (ATP)
n=450 Participants
15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
Total
n=925 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
214 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
417 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
261 Participants
n=99 Participants
|
247 Participants
n=107 Participants
|
508 Participants
n=206 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
409 Participants
n=99 Participants
|
402 Participants
n=107 Participants
|
811 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
180 participants
n=99 Participants
|
169 participants
n=107 Participants
|
349 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
109 participants
n=99 Participants
|
106 participants
n=107 Participants
|
215 participants
n=206 Participants
|
|
Region of Enrollment
France
|
84 participants
n=99 Participants
|
77 participants
n=107 Participants
|
161 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
76 participants
n=99 Participants
|
75 participants
n=107 Participants
|
151 participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: 934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.
Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
Outcome measures
| Measure |
8 Pulses Anti-Tachycardia Pacing (ATP)
n=475 Participants
8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
15 Pulses Anti-Tachycardia Pacing (ATP)
n=450 Participants
15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
|
|---|---|---|
|
Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
|
64.9 Percentage of FVT episodes terminated
|
69.7 Percentage of FVT episodes terminated
|
SECONDARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: one yearOutcome measures
Outcome data not reported
Adverse Events
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