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

Not Applicable

Completed

• Conditions: Sinus Node Disease; Atrial Fibrillation
• Interventions: Device: DDD-40; Device: DDDR-60

• Registration Number: NCT02034526
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Study Start: 2014-05
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DDD-40	DDD-40	DDD, lower pacing rate 40 bpm, RR function off
DDDR-60	DDDR-60	DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
QOL	After 12 months	Quality of life assessment with SF-36
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 death	Within two years	Time to all cause death
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
6MHWT	After 12 months	6-minute hall walk test
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 need for reprogramming of the pacing rate (cross-over)	Within 2 years	Time to need for reprogramming of the pacing rate (cross-over)

Trial Locations

Locations (1)

Department of Cardiology, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark