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Not yet recruiting NCT07354347

Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD

No phase Interventional Heart Disease Implantable Cardioverter Defibrillator (ICD) Heart Rhythm Disorders Ventricular Tachyarrhythmias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Burst, Ramp.
Who it may be relevant to
Registry conditions: Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders, Ventricular Tachyarrhythmias. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)

Overview

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

  • Other Burst
    ATP with 4 burst
  • Other Ramp
    ATP with 1 Burst + 3 Ramp

Primary outcome measures

  • Arrhythmia cessation [Time frame: The lifetime of the ICD, estimated 10 years]
Secondary outcome measures (1)
  • Defibrillation [Time frame: The lifetime of the ICD, estimated 10 years]

Eligibility criteria

Inclusion criteria

\- ICD implantation for primary or secondary prophylactic indication

Exclusion criteria

  • None
  • Patients can actively opt out of participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • The Heart Center, Rigshospitalet — Copenhagen

Identifiers

NCT: NCT07354347 · DAN-ATP · 2501444

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗