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

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Sinus Node Disease
• Intervention / Treatment: Device: DDDR-60; Device: DDD-40

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Cardiology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: DDDR-60; DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)	Device: DDDR-60; DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
Experimental: DDD-40; DDD, lower pacing rate 40 bpm, RR function off	Device: DDD-40; DDD, lower pacing rate 40 bpm, RR function off

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	Quality of life assessment with SF-36	After 12 months
6MHWT	6-minute hall walk test	After 12 months
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	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
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Odense University Hospital; Zealand University Hospital; Rigshospitalet, Denmark; Bispebjerg Hospital; Herning Hospital; Vejle Hospital; Hillerod Hospital, Denmark; Aalborg University Hospital; University Hospital, Gentofte, Copenhagen; Regionshospitalet Viborg, Skive; Hospital of South West Jutland; Aabenraa Hospital
• Investigators: Principal Investigator: Jens C Nielsen, prof., DMSc,, Department of Cardiology, Aarhus University Hospital

Publications and helpful links

Helpful Links

• Publication of the main results

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimated): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Pacing; Sinus node disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Atrial Fibrillation; Sick Sinus Syndrome
• Other Study ID Numbers: M-2013-225-13