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Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02317068
Enrollment
200
Registered
2014-12-15
Start date
2014-01-31
Completion date
2015-10-31
Last updated
2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation, Sick Sinus Syndrome

Keywords

sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing

Brief summary

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.

Interventions

DEVICEHBR
DEVICEDD

Sponsors

Urmia University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial high rate/Automatic mode switch episodesDuring 6 MonthsThe number of AHR/AMS episodes recorded by pacemaker

Secondary

MeasureTime frameDescription
DeathDuring 6 monthsDeath
Heart failureDuring 6 monthsThe development or progression of heart failure during follow-up
Worsening Functional ClassDuring 6 monthsThe worsening of functional class
StrokeDuring 6 monthsThe development of stroke during follow-up
Myocardial infarctionDuring 6 monthsThe development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026