Sinus Node DiseaseDANPACEIINCT02034526
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.
A study testing DDDR-60 and DDD-40 in people with Sinus Node Disease and Atrial Fibrillation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Disease, Atrial Fibrillation
- What is being tested?
- DDDR-60 and DDD-40
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF.
- Age ≥18 years.
- Patient informed consent.
Who cannot join
- Permanent or persisting (>7 days) AF prior to implantation.
- Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring).
- Life expectancy <2 years.
- Participation in another interventional research study.
- Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.
Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF.
The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.
- Conditions
- Sinus Node Disease, Atrial Fibrillation
- Being tested
- DDDR-60, DDD-40
- Keywords
- Sinus node disease, Atrial fibrillation, Pacing
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDDR-60Device
DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
DDD-40Device
DDD, lower pacing rate 40 bpm, RR function off
| Study group | Role | What they receive |
|---|---|---|
| DDDR-60 | Placebo comparator | DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) Receives: Device: DDDR-60 |
| DDD-40 | Experimental | DDD, lower pacing rate 40 bpm, RR function off Receives: Device: DDD-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first episode of AF>6 min detected by the pacemaker
First episode of AF > 6 min detected by the device
Measured: Within two years
Secondary outcomes (8)
Time to first episode of AF>6 hours detected by the pacemaker
First episode of AF > 6 hours detected by the device
Measured: Within two years
Time to first episode of AF>24 hours detected by the pacemaker
First episode of AF > 24 hours detected by the device
Measured: Within two years
Time to direct current (DC) cardioversion or medical cardioversion for AF
Time to direct current (DC) cardioversion or medical cardioversion for AF
Measured: Within two years
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Measured: Within two years
Time to death
Time to all cause death
Measured: Within two years
QOL
Quality of life assessment with SF-36
Measured: After 12 months
6MHWT
6-minute hall walk test
Measured: After 12 months
Time to need for reprogramming of the pacing rate (cross-over)
Time to need for reprogramming of the pacing rate (cross-over)
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMay 2014
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Herning Hospital, Regionshospitalet Viborg, Skive, Aabenraa Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Vejle Hospital, Odense University Hospital, Zealand University Hospital, Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
- Responsible party
- Principal investigator, Jens Cosedis Nielsen, Aarhus University Hospital
- Investigators
- Jens C Nielsen, prof., DMSc,, Principal investigator, Department of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034526
- Sponsor's protocol ID
- M-2013-225-13
- Acronym
- DANPACEII
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2014
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kronborg MB, Frausing MHJP, Malczynski J, Riahi S, Haarbo J, Holm KF, Larroude CE, Albertsen AE, Svendstrup L, Hintze U, Pedersen OD, Davidsen U, Fischer T, Johansen JB, Kristensen J, Gerdes C, Nielsen JC; DANPACE II Investigators. Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4246-4255. doi: 10.1093/eurheartj/ehad564.
PubMed 37638973
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.
- ClinicalTrials.gov ID
- NCT02034526
- Acronym / sponsor ID
- DANPACEII / M-2013-225-13
- Conditions
- Sinus Node Disease, Atrial Fibrillation
- Keywords
- Sinus node disease, Atrial fibrillation, Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Herning Hospital, Regionshospitalet Viborg, Skive, Aabenraa Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Vejle Hospital, Odense University Hospital, Zealand University Hospital, Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital, University Hospital, Gentofte, Copenhagen, Hillerod Hospital, Denmark
- Study start
- May 2014
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Jan 2014 (estimated)
- 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.
Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF.
The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDDR-60 | Placebo comparator | Device: DDDR-60DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) |
| DDD-40 | Experimental | Device: DDD-40DDD, lower pacing rate 40 bpm, RR function off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (>2 sec) or bradycardia with or without paroxysmal AF.
- Age ≥18 years.
- Patient informed consent.
Key exclusion criteria (6 listed)
- Permanent or persisting (>7 days) AF prior to implantation.
- Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of >40 bpm is indicated (verified with long term ECG monitoring).
- Life expectancy <2 years.
- Participation in another interventional research study.
- Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
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 |
|---|---|---|
| DDDR-60DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) | Device | DDDR-60 |
| DDD-40DDD, lower pacing rate 40 bpm, RR function off | Device | DDD-40 |
Primary outcome
Time to first episode of AF>6 min detected by the pacemaker
Time frame: Within two years
First episode of AF > 6 min detected by the device
8 secondary outcomes
Time to first episode of AF>6 hours detected by the pacemaker
Time frame: Within two years
Time to first episode of AF>24 hours detected by the pacemaker
Time frame: Within two years
Time to direct current (DC) cardioversion or medical cardioversion for AF
Time frame: Within two years
Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time frame: Within two years
Time to death
Time frame: Within two years
QOL
Time frame: After 12 months
6MHWT
Time frame: After 12 months
Time to need for reprogramming of the pacing rate (cross-over)
Time frame: Within 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 37638973Kronborg MB, Frausing MHJP, Malczynski J, Riahi S, Haarbo J, Holm KF, Larroude CE, Albertsen AE, Svendstrup L, Hintze U, Pedersen OD, Davidsen U, Fischer T, Johansen JB, Kristensen J, Gerdes C, Nielsen JC; DANPACE II Investigators. Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4246-4255. doi: 10.1093/eurheartj/ehad564.
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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. This study is not recruiting at the moment.
Jens C Nielsen, prof., DMSc, principal investigator
Department of Cardiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDDR-60 and DDD-40 in people with Sinus Node Disease and Atrial Fibrillation, run by Aarhus University Hospital 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first episode of AF>6 min detected by the pacemaker (time frame: Within two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034526, which also lists 1 linked publication.
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 8 Feb 2024.