Back to resultsIncreasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
Primary Purpose
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
HBR
DD
Sponsored by
About this trial
This is an interventional prevention trial for Sick Sinus Syndrome focused on measuring sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing
Eligibility Criteria
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
Sites / Locations
- Seyyed-al-Shohada Heart Center, UMSU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Atrial Base Rate Pacing
Device Default
Arm 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
The base rate of pacemaker will be determined 60 beats/minute
Outcomes
Primary Outcome Measures
Atrial high rate/Automatic mode switch episodes
The number of AHR/AMS episodes recorded by pacemaker
Secondary Outcome Measures
Stroke
The development of stroke during follow-up
Myocardial infarction
The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation
Heart failure
The development or progression of heart failure during follow-up
Worsening Functional Class
The worsening of functional class
Death
Death
Full Information
NCT ID
NCT02317068
First Posted
December 10, 2014
Last Updated
October 20, 2015
Sponsor
Urmia University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02317068
Brief Title
Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Urmia University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, Paroxysmal Atrial Fibrillation
Keywords
sick sinus syndrome, paroxysmal atrial fibrillation, atrial pacing, high atrial base rate pacing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Atrial Base Rate Pacing
Arm Type
Experimental
Arm 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
Arm Title
Device Default
Arm Type
Active Comparator
Arm Description
The base rate of pacemaker will be determined 60 beats/minute
Intervention Type
Device
Intervention Name(s)
HBR
Other Intervention Name(s)
High Atrial Base Rate Pacing
Intervention Type
Device
Intervention Name(s)
DD
Other Intervention Name(s)
Device Default
Primary Outcome Measure Information:
Title
Atrial high rate/Automatic mode switch episodes
Description
The number of AHR/AMS episodes recorded by pacemaker
Time Frame
During 6 Months
Secondary Outcome Measure Information:
Title
Stroke
Description
The development of stroke during follow-up
Time Frame
During 6 months
Title
Myocardial infarction
Description
The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation
Time Frame
During 6 months
Title
Heart failure
Description
The development or progression of heart failure during follow-up
Time Frame
During 6 months
Title
Worsening Functional Class
Description
The worsening of functional class
Time Frame
During 6 months
Title
Death
Description
Death
Time Frame
During 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seyyed-al-Shohada Heart Center, UMSU
City
Urmia
State/Province
West-Azerbaijan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation
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