Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

NCT02317068 | Completed Phase 3 DMC

• 1 other identifier: UMSU-Cardiology-4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sick Sinus Syndrome; Paroxysmal Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Atrial high rate/Automatic mode switch episodes

  The number of AHR/AMS episodes recorded by pacemaker

  During 6 Months

Secondary Outcomes (5)

• Stroke

  During 6 months

• Myocardial infarction

  During 6 months

• Heart failure

  During 6 months

• Worsening Functional Class

  During 6 months

• Death

  During 6 months

Study Arms (2)

High Atrial Base Rate Pacing

EXPERIMENTAL

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

Device Default

ACTIVE COMPARATOR

The base rate of pacemaker will be determined 60 beats/minute

Device: DD

Interventions

HBR DEVICE

Also known as: High Atrial Base Rate Pacing

High Atrial Base Rate Pacing

DD DEVICE

Also known as: Device Default

Device Default

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Urmia University of Medical Sciences: lead

Study Sites (1)

Seyyed-al-Shohada Heart Center, UMSU

Urmia, West Azerbaijan Province, Iran

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chancellor for Research in UMSU

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 15, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

IR (1)