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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 925 participants
• Primary outcome timeframe: one year
• Results posted on: 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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	214 Participants n=5 Participants	203 Participants n=7 Participants	417 Participants n=5 Participants
Age, Categorical >=65 years	261 Participants n=5 Participants	247 Participants n=7 Participants	508 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 10.9 • n=5 Participants	63.4 years STANDARD_DEVIATION 12.2 • n=7 Participants	63.7 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	48 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	409 Participants n=5 Participants	402 Participants n=7 Participants	811 Participants n=5 Participants
Region of Enrollment Italy	180 participants n=5 Participants	169 participants n=7 Participants	349 participants n=5 Participants
Region of Enrollment Germany	109 participants n=5 Participants	106 participants n=7 Participants	215 participants n=5 Participants
Region of Enrollment France	84 participants n=5 Participants	77 participants n=7 Participants	161 participants n=5 Participants
Region of Enrollment Spain	76 participants n=5 Participants	75 participants n=7 Participants	151 participants n=5 Participants
Region of Enrollment Portugal	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Belgium	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Israel	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: 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 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome 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

Laura Manotta

Medtronic Italia S.p.A.

Phone: 003902241371

Email: laura.manotta@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place