NCT00617175

Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,902 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

Detailed description

Primary Objective: The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities. Secondary Objectives: 1. Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes. 2. Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study. 3. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms. 4. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms). 5. Describe the economic impact and the quality of life consequences.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DEVICE	Implantable Defibrillator	Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
DEVICE	Implantable Defibrillator	number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2008-02-15
• Last updated: 2025-07-02
• Results posted: 2013-02-25

Locations

91 sites across 14 countries: Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain