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Completed

NCT Number: NCT02034526

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

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.

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Key information

Conditions

Sinus Node Disease Arrhythmia, Sinus Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DDDR-60

Device

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

DDD-40

Device

DDD, lower pacing rate 40 bpm, RR function off

Primary outcomes

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

    Time frame: Within two years

    First episode of AF > 6 min detected by the device

Secondary outcomes

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

    Time frame: Within two years

    First episode of AF > 6 hours detected by the device

  2. Time to first episode of AF>24 hours detected by the pacemaker

    Time frame: Within two years

    First episode of AF > 24 hours detected by the device

  3. Time to direct current (DC) cardioversion or medical cardioversion for AF

    Time frame: Within two years

    Time to direct current (DC) cardioversion or medical cardioversion for AF

  4. Time to stroke, transient ischemic attack (TIA), or thromboembolic event

    Time frame: Within two years

    Time to stroke, transient ischemic attack (TIA), or thromboembolic event

  5. Time to death

    Time frame: Within two years

    Time to all cause death

  6. QOL

    Time frame: After 12 months

    Quality of life assessment with SF-36

  7. 6MHWT

    Time frame: After 12 months

    6-minute hall walk test

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

    Time frame: Within 2 years

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aabenraa Hospital
  • Aalborg University Hospital
  • Bispebjerg Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Herning Hospital
  • Hillerod Hospital, Denmark
  • Odense University Hospital
  • Regionshospitalet Viborg, Skive
  • Rigshospitalet, Denmark
  • University Hospital, Gentofte, Copenhagen
  • Vejle Hospital
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: DANPACEII

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2014
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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