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Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

U

Urmia University of Medical Sciences

Status and phase

Completed
Phase 3

Conditions

Paroxysmal Atrial Fibrillation
Sick Sinus Syndrome

Treatments

Device: HBR
Device: DD

Study type

Interventional

Funder types

Other

Identifiers

NCT02317068
UMSU-Cardiology-4

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

High Atrial Base Rate Pacing
Experimental group
Description:
The base rate of pacemaker will be determined 75-100 beats/minute in condition that during first step of follow-up, his/her atrial pacing will be more than 80% of atrial high rate/automatic mode switch
Treatment:
Device: HBR
Device Default
Active Comparator group
Description:
The base rate of pacemaker will be determined 60 beats/minute
Treatment:
Device: DD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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