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

N/ACompletedNCT02034526

Aarhus University Hospital540 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

540

Conditions

Sinus Node Disease Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time to first episode of AF>6 min detected by the pacemaker

First episode of AF \> 6 min detected by the device

Time frame: Within two years

Secondary Outcomes

Time to first episode of AF>6 hours detected by the pacemaker

First episode of AF \> 6 hours detected by the device

Time frame: 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

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 to all cause death

Time frame: Within two years

QOL

Quality of life assessment with SF-36

Time frame: After 12 months

6MHWT

6-minute hall walk test

Time frame: After 12 months

Time to need for reprogramming of the pacing rate (cross-over)

Time frame: Within 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes