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Completed

NCT Number: NCT02317068

Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

This study aims to determine whether increasing atrial base rate pacing to achieve at least 75-80% atrial pacing in patients with sick sinus syndrome undergoing the implementation of dual-chamber pacemaker can be useful to prevent or decrease the atrial fibrillation during 6 months follow-up duration.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seyyed-al-Shohada Heart Center, UMSU

Urmia, West Azerbaijan Province, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sick sinus syndrome patients having dual-chamber pacemaker
  • Having paroxysmal AF defined as at least 2 episodes of AHR/AMS >190 b/min lasting >6 minutes
  • Having normal atrioventricular conduction

Exclusion criteria

  • Other clinical indications for pacing except sick sinus syndrome (bradycardia-tachycardia syndrome)
  • History of acute coronary syndrome
  • Significant heart valve disease
  • Chronic AF before randomization
  • Overt heart failure
  • Malignancy
  • Any reasons for antiarrhythmic medication use
  • Inability to follow patients every 3 months

Treatment and study plan

HBR

Device

Other names: High Atrial Base Rate Pacing

DD

Device

Other names: Device Default

Primary outcomes

  1. Atrial high rate/Automatic mode switch episodes

    Time frame: During 6 Months

    The number of AHR/AMS episodes recorded by pacemaker

Secondary outcomes

  1. Stroke

    Time frame: During 6 months

    The development of stroke during follow-up

  2. Myocardial infarction

    Time frame: During 6 months

    The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation

  3. Heart failure

    Time frame: During 6 months

    The development or progression of heart failure during follow-up

  4. Worsening Functional Class

    Time frame: During 6 months

    The worsening of functional class

  5. Death

    Time frame: During 6 months

    Death

Sponsors and collaborators

Lead sponsor

Urmia University of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2014
Registry last updated
Oct 21, 2015

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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