Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

A Randomised Controlled Trial of Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome and Dual Chamber Pacemaker.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02034526

Acronym

DANPACEII

Enrollment

540

Registered

2014-01-13

Start date

2014-05-31

Completion date

2023-03-31

Last updated

2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Sinus Node Disease

Keywords

Sinus node disease, Atrial fibrillation, Pacing

Brief 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. 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.

Interventions

DEVICEDDDR-60

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

DEVICEDDD-40

DDD, lower pacing rate 40 bpm, RR function off

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Time to first episode of AF>6 min detected by the pacemaker	Within two years	First episode of AF \> 6 min detected by the device

Secondary

Measure	Time frame	Description
Time to first episode of AF>24 hours detected by the pacemaker	Within two years	First episode of AF \> 24 hours detected by the device
Time to direct current (DC) cardioversion or medical cardioversion for AF	Within two years	Time to direct current (DC) cardioversion or medical cardioversion for AF
Time to stroke, transient ischemic attack (TIA), or thromboembolic event	Within two years	Time to stroke, transient ischemic attack (TIA), or thromboembolic event
Time to first episode of AF>6 hours detected by the pacemaker	Within two years	First episode of AF \> 6 hours detected by the device
QOL	After 12 months	Quality of life assessment with SF-36
6MHWT	After 12 months	6-minute hall walk test
Time to need for reprogramming of the pacing rate (cross-over)	Within 2 years	Time to need for reprogramming of the pacing rate (cross-over)
Time to death	Within two years	Time to all cause death

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026