Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 3,980
- Locations
- 2
- Primary Endpoint
- Arrhythmia cessation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- ICD implantation for primary or secondary prophylactic indication
Exclusion Criteria
- •Patients can actively opt out of participation in the study
Arms & Interventions
Burst
Intervention: Burst (Other)
Ramp
Intervention: Ramp (Other)
Outcomes
Primary Outcomes
Arrhythmia cessation
Time Frame: The lifetime of the ICD, estimated 10 years
The ability of the given ATP protocol to stop the ventricular arrhythmia
Secondary Outcomes
- Defibrillation(The lifetime of the ICD, estimated 10 years)
Investigators
Bo Gregers Winkel
Chief Physician
Rigshospitalet, Denmark