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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation; Sick Sinus Syndrome
• Intervention / Treatment: Device: HBR; Device: DD

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • West-Azerbaijan
    • Urmia, West-Azerbaijan, Iran, Islamic Republic of
      • Seyyed-al-Shohada Heart Center, UMSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Atrial Base Rate Pacing; 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: HBR; Other Names: High Atrial Base Rate Pacing
ACTIVE_COMPARATOR: Device Default; The base rate of pacemaker will be determined 60 beats/minute	Device: DD; Other Names: Device Default

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial high rate/Automatic mode switch episodes	The number of AHR/AMS episodes recorded by pacemaker	During 6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Urmia University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (ESTIMATE): December 15, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: paroxysmal atrial fibrillation; atrial pacing; sick sinus syndrome; high atrial base rate pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Atrial Fibrillation; Sick Sinus Syndrome
• Other Study ID Numbers: UMSU-Cardiology-4