Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders, Ventricular Tachyarrhythmias
Conditions
Keywords
Heart failure, ICD, ATP, Anti Takykardi Pacing, Implantable Cardioverter Defibrillator, cluster randomisation, heart rhythm disorder, ventricular tachyarrhythmias, VT
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.
Interventions
OTHERBurst
ATP with 4 burst
OTHERRamp
ATP with 1 Burst + 3 Ramp
Sponsors
Rigshospitalet, Denmark
The Novo Nordic Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a pragmatic, two-group, cluster randomized trial. With clusters of time periods of 4-month duration at all sites.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- ICD implantation for primary or secondary prophylactic indication
Exclusion criteria
* None * Patients can actively opt out of participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia cessation | The lifetime of the ICD, estimated 10 years | The ability of the given ATP protocol to stop the ventricular arrhythmia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Defibrillation | The lifetime of the ICD, estimated 10 years | Arrhythmia accelerates resulting in defibrillation/shock therapy |
Countries
Denmark
Contacts
CONTACTBo G Winkel, MD, PhD
Outcome results
None listed