The Heart Center, Rigshospitalet
Copenhagen, Dr., 2100, Denmark
Location contact
Bo G Winkel, MD, PhD
CONTACT
Bo G winkel, MD, PhD
PRINCIPAL_INVESTIGATOR
winkel
CONTACT
NCT Number: NCT07354347
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Dr., 2100, Denmark
Bo G Winkel, MD, PhD
CONTACT
Bo G winkel, MD, PhD
PRINCIPAL_INVESTIGATOR
winkel
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ATP with 4 burst
ATP with 1 Burst + 3 Ramp
Time frame: The lifetime of the ICD, estimated 10 years
The ability of the given ATP protocol to stop the ventricular arrhythmia
Time frame: The lifetime of the ICD, estimated 10 years
Arrhythmia accelerates resulting in defibrillation/shock therapy
Contact information is provided by the study sponsor or research team.
Rigshospitalet, Denmark
Other
Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)
Acronym: DAN-ATP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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