Heart DiseaseDAN-ATPNCT07354347
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
A study testing Burst and Ramp in people with Heart Disease and Implantable Cardioverter Defibrillator (ICD), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders
- What is being tested?
- Burst and Ramp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,980 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 31 Jul 2041
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD implantation for primary or secondary prophylactic indication
Who cannot join
- None
- Patients can actively opt out of participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
The Heart Center, Rigshospitalet
Copenhagen, Dr., 2100
Bo G Winkel, MD, PhD, 35459759, bo.winkel@regionh.dk
winkel, bo.winkel@regionh.dk
About this study
Official title: 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.
Read more
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
- Being tested
- Burst, Ramp
- Keywords
- Heart failure, ICD, ATP, Anti Takykardi Pacing, Implantable Cardioverter Defibrillator, cluster randomisation, heart rhythm disorder, ventricular tachyarrhythmias, VT
- Medical subject headings
- Heart Diseases, Arrhythmias, Cardiac, Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurstOther
ATP with 4 burst
RampOther
ATP with 1 Burst + 3 Ramp
| Study group | Role | What they receive |
|---|---|---|
| Burst | Experimental | Not described Receives: Other: Burst |
| Ramp | Experimental | Not described Receives: Other: Ramp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia cessation
The ability of the given ATP protocol to stop the ventricular arrhythmia
Measured: The lifetime of the ICD, estimated 10 years
Secondary outcomes (1)
Defibrillation
Arrhythmia accelerates resulting in defibrillation/shock therapy
Measured: The lifetime of the ICD, estimated 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Feb 2026
- Primary completion31 Jul 2041 (estimated)
- Study completion31 Jul 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a pragmatic, two-group, cluster randomized trial. With clusters of time periods of 4-month duration at all sites.
- Masking
- None (open label)
- Enrolment
- 3,980 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Principal investigator, Bo Gregers Winkel, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354347
- Sponsor's protocol ID
- DAN-ATP
- Other IDs
- 2501444
- Acronym
- DAN-ATP
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are considered sensitive personal data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal ATP Settings in the VT Zone for New Implantable Cardioverter Defibrillator (ICD) Implantation (DAN-ATP)
- ClinicalTrials.gov ID
- NCT07354347
- Acronym / sponsor ID
- DAN-ATP / DAN-ATP
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,980 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2041 (estimated)
- Study completion
- 31 Jul 2041 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a pragmatic, two-group, cluster randomized trial. With clusters of time periods of 4-month duration at all sites.
| Arm | Type | Receives |
|---|---|---|
| Burst | Experimental | Other: Burst |
| Ramp | Experimental | Other: Ramp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICD implantation for primary or secondary prophylactic indication
Key exclusion criteria (2 listed)
- None
- Patients can actively opt out of participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BurstATP with 4 burst | Other | Burst |
| RampATP with 1 Burst + 3 Ramp | Other | Ramp |
Primary outcome
Arrhythmia cessation
Time frame: The lifetime of the ICD, estimated 10 years
The ability of the given ATP protocol to stop the ventricular arrhythmia
1 secondary outcome
Defibrillation
Time frame: The lifetime of the ICD, estimated 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. The data are considered sensitive personal data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst and Ramp in people with Heart Disease and Implantable Cardioverter Defibrillator (ICD), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo G Winkel, MD, PhD (+4535459759, bo.winkel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia cessation (time frame: The lifetime of the ICD, estimated 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.