Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

Phase 3

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Sick Sinus Syndrome
• Interventions: Device: HBR; Device: DD

• Registration Number: NCT02317068
• Lead Sponsor: Urmia University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Atrial Base Rate Pacing	HBR	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
Device Default	DD	The base rate of pacemaker will be determined 60 beats/minute

Primary Outcome Measures

Name	Time	Method
Atrial high rate/Automatic mode switch episodes	During 6 Months	The number of AHR/AMS episodes recorded by pacemaker

Secondary Outcome Measures

Name	Time	Method
Stroke	During 6 months	The development of stroke during follow-up
Myocardial infarction	During 6 months	The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation
Worsening Functional Class	During 6 months	The worsening of functional class
Death	During 6 months	Death
Heart failure	During 6 months	The development or progression of heart failure during follow-up

Trial Locations

Locations (1)

Seyyed-al-Shohada Heart Center, UMSU; 🇮🇷 Urmia, West-Azerbaijan, Iran, Islamic Republic of