Trial Outcomes & Findings for ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy (NCT NCT00147290)

NCT ID: NCT00147290

Last Updated: 2025-07-02

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: 526 participants
• Primary outcome timeframe: one year
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	Right Ventricle (RV) Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle	Biventricular (BiV) Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
Overall Study STARTED	266	260
Overall Study COMPLETED	266	260
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy

Baseline characteristics by cohort

Measure	Right Ventricle (RV) n=266 Participants Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle	Biventricular (BiV) n=260 Participants Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles	Total n=526 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	94 Participants n=5 Participants	95 Participants n=7 Participants	189 Participants n=5 Participants
Age, Categorical >=65 years	172 Participants n=5 Participants	165 Participants n=7 Participants	337 Participants n=5 Participants
Age, Continuous	66.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	66.8 years STANDARD_DEVIATION 9.5 • n=7 Participants	66.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	231 Participants n=5 Participants	218 Participants n=7 Participants	449 Participants n=5 Participants
Region of Enrollment Italy	122 participants n=5 Participants	127 participants n=7 Participants	249 participants n=5 Participants
Region of Enrollment France	67 participants n=5 Participants	61 participants n=7 Participants	128 participants n=5 Participants
Region of Enrollment Germany	48 participants n=5 Participants	46 participants n=7 Participants	94 participants n=5 Participants
Region of Enrollment Spain	22 participants n=5 Participants	20 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment Israel	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Portugal	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

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	Right Ventricle (RV) n=260 Participants Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle	Biventricular (BiV) n=266 Participants Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.	64.7 Percent of VT episodes terminated	68.2 Percent of VT 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

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elisabetta Santi

Medtronic

Phone: 003906328141

Email: elisabetta.santi@medtronic.com

Results disclosure agreements

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