Status:
COMPLETED
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-...
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 (C...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1902 Patients enrolled
Trial Details
Trial ID
NCT00617175
Start Date
March 1 2008
End Date
February 1 2012
Last Update
July 2 2025
Active Locations (91)
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1
Hopital St-Joseph
Gilly, Belgium
2
CHU Brugmann
Laken, Belgium
3
CHR La Citadelle Liege
Liège, Belgium
4
CHR Namur
Namur, Belgium