Sick Sinus Syndrome, Atrial Fibrillation Sick Sinus Syndrome, Atrial Fibrillation, Pacemaker
Conditions
Interventions
Patients with sick sinus syndrome who require pacemaker implantation will be randomly assigned to either the conventional right atrial appendage pacing group or the Bachmanns bundle pacing group for a
pacemaker implantation
Sponsors
Takami Mitsuru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing implantation of a DDD pacemaker for one of the following types of sick sinus syndrome: Symptomatic sick sinus syndrome or sick sinus syndrome considered to contribute to heart failure Tachycardia bradycardia syndrome in which essential therapy for tachyarrhythmia induces bradycardia Asymptomatic sinoatrial block or sinus arrest 2) Patients with no prior history of atrial fibrillation, atrial flutter, or atrial tachycardia 3) Patients aged 20 years or older at the time of informed consent 4) Patients who are able to complete 2 years of follow up 5) Patients who provide written informed consent based on their own free will
Exclusion criteria
Exclusion criteria: 1) Patients who meet any of the following conditions will be excluded: 2) Patients with atrioventricular block requiring ventricular pacing 3) Patients with a history of open heart surgery 4) Patients who are pregnant 5) Patients with a mechanical tricuspid valve 6) Patients with a contraindication to beclomethasone dipropionate used in steroid eluting leads 7) Patients with obstructed or inadequate veins that make venous catheter insertion impossible 8) Patients judged by the investigators to be otherwise unsuitable for this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to New Onset Atrial Arrhythmia Definition: Time from pacemaker implantation to the first occurrence of atrial fibrillation, atrial tachycardia, or atrial flutter lasting over 30 seconds as detected by the pacemaker. Patients without new-onset atrial arrhythmias during the follow up period will be censored at the date of their last observation. Because the pacemaker automatically stores the date and time of arrhythmic events, these device-recorded timestamps will be used to determine the endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| During the procedure and hospitalization Implantation success rate Calculated using all patients who underwent the pacemaker implantation procedure as the denominator. For the Bachmann bundle pacing group, the numerator consists of patients in whom the planned atrial lead was successfully implanted and the predefined criteria for Bachmann bundle pacing were met. For the right atrial appendage pacing group, the numerator consists of patients in whom lead position and movement under fluoroscopy confirmed placement in the right atrial appendage and the procedure was completed as intended. Implantation refers to placement of the pacemaker and leads within the body. Total procedure time Time from skin incision to completion of wound closure. Atrial lead placement time Time from initiation of intravascular insertion of the atrial lead to completion of lead fixation at the final target position. Total fluoroscopy time during the procedure: Total fluoroscopy time used from entry to exit from the procedure room. In-hospital device parameters Battery status, pacing threshold, atrial sensing amplitude, lead impedance, and pacing percentage. In-hospital complications Lead dislodgement, lead perforation, pneumothorax, vascular injury, and thromboembolism. Presence of pacing related chest symptoms After discharge, at 2 years, then annually Device parameters Battery status and pacing percentage. Lead parameters Pacing threshold, atrial sensing amplitude, and lead impedance. Number of atrial fibrillation events (onset time, duration) Time to first occurrence of the following events For non cardiovascular events, the total number of occurrences not only the first will also be recorded All cause death Cardiovascular death Heart failure hospitalization Thromboembolic events Major bleeding Progression to sustained atrial fibrillation Electrical cardioversion for atrial fibrillation or atrial tachycardia/flutter Catheter ablation for atrial fibrillation or atrial tachycardia flutter L | — |
Contacts
Public ContactMitsuru Takami
Kobe University Hospital
Outcome results
None listed