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Trial record 12 of 62 for:    "Sick Sinus Syndrome"

Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02317068
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Chancellor of research, 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.

Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome Paroxysmal Atrial Fibrillation Device: HBR Device: DD Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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 Name: High Atrial Base Rate Pacing

Active Comparator: Device Default
The base rate of pacemaker will be determined 60 beats/minute
Device: DD
Other Name: Device Default




Primary Outcome Measures :
  1. Atrial high rate/Automatic mode switch episodes [ Time Frame: During 6 Months ]
    The number of AHR/AMS episodes recorded by pacemaker


Secondary Outcome Measures :
  1. Stroke [ Time Frame: During 6 months ]
    The development of stroke during follow-up

  2. Myocardial infarction [ Time Frame: During 6 months ]
    The development of MI during follow-up confirmed by ischemic chest pain, 12-ECG, or cardiac enzyme elevation

  3. Heart failure [ Time Frame: During 6 months ]
    The development or progression of heart failure during follow-up

  4. Worsening Functional Class [ Time Frame: During 6 months ]
    The worsening of functional class

  5. Death [ Time Frame: During 6 months ]
    Death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317068


Locations
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Iran, Islamic Republic of
Seyyed-al-Shohada Heart Center, UMSU
Urmia, West-Azerbaijan, Iran, Islamic Republic of
Sponsors and Collaborators
Urmia University of Medical Sciences

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Responsible Party: Chancellor of research, Vice-Chancellor for Research in UMSU, Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02317068     History of Changes
Other Study ID Numbers: UMSU-Cardiology-4
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Chancellor of research, Urmia University of Medical Sciences:
sick sinus syndrome
paroxysmal atrial fibrillation
atrial pacing
high atrial base rate pacing

Additional relevant MeSH terms:
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Atrial Fibrillation
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block
Cardiac Conduction System Disease