Clinical trial NCT02034526: Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinus Node Disease
Atrial Fibrillation
Keywords: Sinus node disease
Atrial fibrillation
Pacing
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Herning Hospital
name: Regionshospitalet Viborg, Skive
name: Aabenraa Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Vejle Hospital
name: Odense University Hospital
name: Zealand University Hospital
name: Rigshospitalet, Denmark
name: Bispebjerg Hospital
name: University Hospital, Gentofte, Copenhagen
name: Hillerod Hospital, Denmark
First posted: 2014-01-13
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to first episode of AF>6 min detected by the pacemaker
timeFrame: Within two years
Secondary outcomes:
measure: Time to first episode of AF>6 hours detected by the pacemaker
timeFrame: Within two years
measure: Time to first episode of AF>24 hours detected by the pacemaker
timeFrame: Within two years
measure: Time to direct current (DC) cardioversion or medical cardioversion for AF
timeFrame: Within two years
measure: Time to stroke, transient ischemic attack (TIA), or thromboembolic event
timeFrame: Within two years
measure: Time to death
timeFrame: Within two years
measure: QOL
timeFrame: After 12 months
measure: 6MHWT
timeFrame: After 12 months
measure: Time to need for reprogramming of the pacing rate (cross-over)
timeFrame: Within 2 years
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital
Study officials:
affiliation: Department of Cardiology, Aarhus University Hospital
name: Jens C Nielsen, prof., DMSc,
role: PRINCIPAL_INVESTIGATOR
References: