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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07354347

Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
3,980 (estimated)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBurstATP with 4 burst
OTHERRampATP with 1 Burst + 3 Ramp

Timeline

Start date
2026-02-01
Primary completion
2041-07-31
Completion
2041-07-31
First posted
2026-01-21
Last updated
2026-01-27

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT07354347. Inclusion in this directory is not an endorsement.