Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317068
• Other study ID #: UMSU-Cardiology-4
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2014
• Last updated: October 20, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation
• Sick Sinus Syndrome

Intervention

Device:
• HBR

• DD

Locations

Country	Name	City	State
Iran, Islamic Republic of	Seyyed-al-Shohada Heart Center, UMSU	Urmia	West-Azerbaijan

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial high rate/Automatic mode switch episodes	The number of AHR/AMS episodes recorded by pacemaker	During 6 Months	No
Secondary	Stroke	The development of stroke during follow-up	During 6 months	Yes
Secondary	Myocardial infarction	The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation	During 6 months	Yes
Secondary	Heart failure	The development or progression of heart failure during follow-up	During 6 months	Yes
Secondary	Worsening Functional Class	The worsening of functional class	During 6 months	Yes
Secondary	Death	Death	During 6 months	No