None listed
Conditions
Brief summary
The scientific literature shows that there is an increased risk of developing AF in patients implanted with a pacemaker due to sinus node dysfunction. To overcome this, advance algorithms were developed to reduce the AF burden. The purpose of this study is to evaluate whether the specific pacemaker algorithms in question contribute to the suppression of AF. It is expected that the finding of this research will aid in the development of best practice guidelines for patients with pacemaker devices.
Interventions
Dual chamber pacemaker device - MVP+APP+aATP algorithm group
Intervention period: 12 months
1. Managed ventricular pacing
MVP is an atrial-based pacing mode that is designed to switch to a dual-chamber pacing mode in the presence of AV block. Specifically, MVP provides the following functions:
*AAI(R) mode pacing when AV conduction is intact
*The ability to switch to DDD(R) pacing during AV block
*Periodic conduction checks while operating in DDD(R) mode, with the ability to switch back to AAI
Dual chamber pacemaker device - MVP+APP+aATP algorithm group Intervention period: 12 months 1. Managed ventricular pacing MVP is an atrial-based pacing mode that is designed to switch to a dual-chamber pacing mode in the presence of AV block. Specifically, MVP provides the following functions: *AAI(R) mode pacing when AV conduction is intact *The ability to switch to DDD(R) pacing during AV block *Periodic conduction checks while operating in DDD(R) mode, with the ability to switch back to AAI(R) mode when AV conduction resumes *Back-up ventricular support for transient loss of AV conduction 2. Atrial Preference Pacing (APP) The device includes three atrial preventive pacing algorithms designed to eliminate some of the onset mechanisms of atrial tachyarrhythmias and to reduce the incidence of atrial tachyarrhythmias. These atrial pacing features comprise the atrial pacing preference algorithm, for maintenance of a pacing rate just above the intrinsic rate, the atrial rate stabilization algorithm, designed to avoid short-long intervals following a premature atrial contraction, and the post-mode switching overdrive pacing algorithm designed to inhibit early re-initiation of atrial tachyarrhythmia following a mode switching episode. 3. Reactive atrial Anti-tachycardia pacing If the device detects an atrial tachyarrhythmia episode, aATP therapy will be delivered. Treatments for such episodes are intended to interrupt the atrial tachycardia and restore patient’s normal sinus rhythm. The device can deliver up to 3 aATP therapies to treat an AT/AF or a Fast AT/AF episode. aATP therapies become available when the duration of sustained atrial tachyarrhythmias exceeds the programmed value of episode duration before aATP delivery - which in this study will be set at 0 minute. When an AT/AF or Fast AT/AF episode is detected, the device delivers the first sequence of the ATP therapy. After the first ATP sequence, it continues to monitor for the presence of the atrial tachycardia episode. If it redetects the atrial tachycardia episode, the device and repeats this cycle until the episode is terminated or all sequences in the therapy are exhausted.
Sponsors
Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. The patient has a dual chamber pacemaker capable of atrial anti-tachycardia based therapy, b. Had AF ablation at least 3 months prior to recruitment, c. AF/atrial arrhythmia burden >0.1% and <30%, d. greater than or equal to 18 years of age
Exclusion criteria
a. Atrioventricular block with ventricular pacing >40 percent, b. Atrial fibrillation episode >90 days. However, presence of prolonged episodes of atrial flutter will not be an exclusion corner, c. Absence of indication for cardiac resynchronization or defibrillator, d. Had < 12 months of life expectancy, e. Cardiac surgery in the last six months, or expected during 12 months of study period, f. A recent history of (< 1 year) or current malignancy, advanced heart failure (NYHA class IV), end-stage chronic obstructive pulmonary disease or other severe life-threatening comorbidities within 3 months of diagnosis, or g. Unable to provide consent.
Outcome results
None listed