Heart Disease Clinical Trial
Official title:
ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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