None listed
Conditions
Brief summary
We propose a randomised control trial to explore whether pacemaker programming, specifically an increased atrial pacing rate, can improve atrial fibrillation (AF) outcomes for older patients with concurrent sinus node disease. Participants will be randomised to either an increased atrial pacing rate, or atrial back-up pacing. The primary outcome will be AF burden.
Interventions
This is a randomised control trial for older patients with both atrial fibrillation (AF) and sinus node dysfunction to expore whether pacemaker programming can decrease the risk of AF recurrence following catheter ablation. All patients will recieve catheter ablation for AF. Patients in the intervention arm will have their pacemaker programmed to a higher atrial pacing rate - termed "increased atrial pacing" (Dual-chamber rate-modulated (DDDR) at 70bpm for all patients in the intervention arm) w
This is a randomised control trial for older patients with both atrial fibrillation (AF) and sinus node dysfunction to expore whether pacemaker programming can decrease the risk of AF recurrence following catheter ablation. All patients will recieve catheter ablation for AF. Patients in the intervention arm will have their pacemaker programmed to a higher atrial pacing rate - termed "increased atrial pacing" (Dual-chamber rate-modulated (DDDR) at 70bpm for all patients in the intervention arm) which will be reprogrammed by the study investigators at the randomisation visit. Patients will be followed up at 3, 6, 9 and 12 months post randomisation, where data from the pacemaker can be reviewed to check adherence to the intervention
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 65 Persistent AF, undergoing AF catheter ablation Ongoing documented sinus node disease at least 1 month following catheter ablation, defined as: - Fatigue, presyncope, dyspnoea, reduced exercise tolerance, or other symptoms that can correlate with slower heart rate, and at least one of the following: Mean sinus rhythm heart rate 80% max predicted heart rate on exercise stress test OR Mean sinus rhythm heart rate <60bpm on Holter monitor Medicare eligible, able to consent, and able to adhere to follow-up requirements
Exclusion criteria
Contraindication to catheter ablation or pacemaker implantation.
Outcome results
None listed