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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Heart Disease

Treatments: Device: Implantable Defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617175

ADVANCE III

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,902 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
• Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.

Exclusion criteria

• ICD replacements and upgrading.
• Brugada Syndrome, Long QT and HCM patients
• Ventricular tachyarrhythmia associated with reversible cause.
• Other electrical implantable devices (Neurostimulators, etc.).
• Subject's life expectancy less than 1 year.
• Subject on heart transplant list which is expected in less than 1 year.
• Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
• Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
• Unwillingness or inability to provide written informed consent.
• Enrolment in, or intention to participate in, another clinical trial.
• Inaccessibility to come to the study center for the follow-up visits.
• Mechanical tricuspid valve.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,902 participants in 2 patient groups

Long NID

Experimental group

Description:

Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia

Treatment:

Device: Implantable Defibrillator

Device: Implantable Defibrillator

Short NID

Active Comparator group

Description:

Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia

Treatment:

Device: Implantable Defibrillator

Device: Implantable Defibrillator