Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD

NCT07354347 | Not Yet Recruiting

• 2 other identifiers: DAN-ATP2501444
• Study Type: interventional
• Target: 3,980
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Implantable Cardioverter Defibrillator (ICD); Heart Rhythm Disorders; Ventricular Tachyarrhythmias

Keywords

Heart failure; ICD; ATP; Anti Takykardi Pacing; Implantable Cardioverter Defibrillator; cluster randomisation; heart rhythm disorder; ventricular tachyarrhythmias; VT

Outcome Measures

Primary Outcomes (1)

• Arrhythmia cessation

  The ability of the given ATP protocol to stop the ventricular arrhythmia

  The lifetime of the ICD, estimated 10 years

Secondary Outcomes (1)

• Defibrillation

  The lifetime of the ICD, estimated 10 years

Study Arms (2)

Burst

EXPERIMENTAL

Other: Burst

Ramp

EXPERIMENTAL

Other: Ramp

Interventions

Burst OTHER

ATP with 4 burst

Burst

Ramp OTHER

ATP with 1 Burst + 3 Ramp

Ramp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ICD implantation for primary or secondary prophylactic indication

You may not qualify if:

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

Sponsors & Collaborators

• The Novo Nordic Foundation: collaborator
• Rigshospitalet, Denmark: lead

Study Sites (1)

The Heart Center, Rigshospitalet

Copenhagen, Dr., 2100, Denmark

Location

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac; Tachycardia, Ventricular; Heart Failure

Interventions

Architectural Accessibility

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Central Study Contacts

Bo G Winkel, MD, PhD

CONTACT

+4535459759; bo.winkel@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: The study is a pragmatic, two-group, cluster randomized trial. With clusters of time periods of 4-month duration at all sites.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2041
• Study Completion (Estimated): July 31, 2041
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)