Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD (DAN-ATP)
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About
This is a pragmatic, two-group, cluster randomized trial designed to compare strategies for the Anti Tachycardia Pacing (ATP)-setting in the ventricular tachyarrhythmias (VT) zone when implanting a new implantable cardioverter defibrillator (ICD) in patients with heart disease in hospitals in Denmark.
The strategies are: "Burst" or "Ramp" after 1. ATP (which is always burst) in VT zone. VT zone is defined between 180-249 (up to 269 in special cases) heartbeats per minute.
The ICD will give either:
Burst: The ICD is programmed to give ATP with 4 bursts. Or Ramp: The ICD is programmed to give ATP with 1 burst and 3 ramps.
The participating hospitals will be assigned to one of two intervention strategies for periods of 4-months. The given intervention will follow the patient/ICD throughout the life time of the ICD, but with the possibility to reprogram at any time (intention to treat).
It is calculated that the study needs a total of 398 events (second to fourth ATP), which is estimated to require 3980 implanted ICDs. The participants will be followed until the end of the ICD life, which is estimated to be around 10 years.
Enrollment
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Inclusion criteria
- ICD implantation for primary or secondary prophylactic indication
Exclusion criteria
- None
- Patients can actively opt out of participation in the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
3,980 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Bo G Winkel, MD, PhD
Data sourced from clinicaltrials.gov
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