Increasing Atrial Base Rate Pacing to Reduce Atrial Fibrillation

NCT ID: NCT02317068

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sick Sinus Syndrome Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

HBR

Intervention Type DEVICE

Device Default

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

Group Type ACTIVE_COMPARATOR

DD

Intervention Type DEVICE

Interventions

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HBR

Intervention Type DEVICE

DD

Intervention Type DEVICE

Other Intervention Names

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High Atrial Base Rate Pacing Device Default

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Urmia University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Chancellor of research

Vice-Chancellor for Research in UMSU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seyyed-al-Shohada Heart Center, UMSU

Urmia, West Azerbaijan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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UMSU-Cardiology-4

Identifier Type: -

Identifier Source: org_study_id

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