NCT00147290

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

ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation. The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.

Detailed description

Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP Secondary objectives: * Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT) * Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT) * Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT) * Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF

Conditions

• Tachycardia, Ventricular
• Ventricular Fibrillation

Interventions

Type	Name	Description
DEVICE	Implantable Cardiac Defibrillator	Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-04-01
• Completion: 2008-01-01
• First posted: 2005-09-07
• Last updated: 2025-07-02
• Results posted: 2009-06-10

Locations

1 site across 1 country: Italy