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| Name | Class |
|---|---|
| Aalborg University Hospital | OTHER |
| Herning Hospital | OTHER |
| Regionshospitalet Viborg, Skive | OTHER |
| Aabenraa Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDDR-60 | Placebo Comparator | DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) |
|
| DDD-40 | Experimental | DDD, lower pacing rate 40 bpm, RR function off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDDR-60 | Device | DDDR, lower pacing rate 60 bpm, RR activated (low-moderate) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first episode of AF>6 min detected by the pacemaker | First episode of AF > 6 min detected by the device | Within two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first episode of AF>6 hours detected by the pacemaker | First episode of AF > 6 hours detected by the device | Within two years |
| Time to first episode of AF>24 hours detected by the pacemaker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens C Nielsen, prof., DMSc, | Department of Cardiology, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37638973 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Feb 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Vejle Hospital | OTHER |
| Odense University Hospital | OTHER |
| Zealand University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Bispebjerg Hospital | OTHER |
| University Hospital, Gentofte, Copenhagen | OTHER |
| Hillerod Hospital, Denmark | OTHER |
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| DDD-40 |
| Device |
DDD, lower pacing rate 40 bpm, RR function off |
|
First episode of AF > 24 hours detected by the device
| 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 | Within two years |
| Time to stroke, transient ischemic attack (TIA), or thromboembolic event | Time to stroke, transient ischemic attack (TIA), or thromboembolic event | Within two years |
| Time to death | Time to all cause death | Within two years |
| QOL | Quality of life assessment with SF-36 | After 12 months |
| 6MHWT | 6-minute hall walk test | 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) | Within 2 years |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |