Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome.

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

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2023-03-31

Brief Summary

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Atrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF.

The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.

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Detailed Description

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Conditions

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Sinus Node Disease Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DDDR-60

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Group Type PLACEBO_COMPARATOR

DDDR-60

Intervention Type DEVICE

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

DDD-40

DDD, lower pacing rate 40 bpm, RR function off

Group Type EXPERIMENTAL

DDD-40

Intervention Type DEVICE

DDD, lower pacing rate 40 bpm, RR function off

Interventions

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DDDR-60

DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)

Intervention Type DEVICE

DDD-40

DDD, lower pacing rate 40 bpm, RR function off

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Sick sinus syndrome with and without AV block and indication for first-time implantation of a DDD pacemaker: symptomatic sinus pauses (\>2 sec) or bradycardia with or without paroxysmal AF.
* Age ≥18 years.
* Patient informed consent.

Exclusion Criteria

* Permanent or persisting (\>7 days) AF prior to implantation.
* Persisting symptomatic sinus bradycardia and/or chronotropic incompetence where DDD-pacing at a frequency of \>40 bpm is indicated (verified with long term ECG monitoring).
* Life expectancy \<2 years.
* Participation in another interventional research study.
* Indication for implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT).
* Pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No