- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354347
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD (DAN-ATP)
Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bo G Winkel, MD, PhD
- Phone Number: +4535459759
- Email: bo.winkel@regionh.dk
Study Locations
-
-
Dr.
-
Copenhagen, Dr., Denmark, 2100
- Recruiting
- The Heart Center, Rigshospitalet
-
Contact:
- Bo G Winkel, MD, PhD
- Phone Number: 35459759
- Email: bo.winkel@regionh.dk
-
Contact:
- winkel
- Email: bo.winkel@regionh.dk
-
Principal Investigator:
- Bo G winkel, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ICD implantation for primary or secondary prophylactic indication
Exclusion Criteria:
- None
- Patients can actively opt out of participation in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Burst
|
ATP with 4 burst
|
|
Experimental: Ramp
|
ATP with 1 Burst + 3 Ramp
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrhythmia cessation
Time Frame: The lifetime of the ICD, estimated 10 years
|
The ability of the given ATP protocol to stop the ventricular arrhythmia
|
The lifetime of the ICD, estimated 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Defibrillation
Time Frame: The lifetime of the ICD, estimated 10 years
|
Arrhythmia accelerates resulting in defibrillation/shock therapy
|
The lifetime of the ICD, estimated 10 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiac Conduction System Disease
- Cardiovascular Diseases
- Pathologic Processes
- Tachycardia
- Pathological Conditions, Signs and Symptoms
- Heart Failure
- Heart Diseases
- Tachycardia, Ventricular
- Arrhythmias, Cardiac
- Technology, Industry, and Agriculture
- Facility Design and Construction
- Architecture
- Architectural Accessibility
Other Study ID Numbers
- DAN-ATP
- 2501444 (Other Identifier: VMK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.