Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Tong Ren Hospital
About this trial
This study aims to evaluate whether posterosuperior bundle (PSB) pacing reduces the incidence of atrial fibrillation (AF) in patients with sinus node dysfunction (SND) undergoing pacemaker implantation. Approximately 300 patients will be enrolled and randomized to receive atrial pacing at either the PSB region or the right atrial appendage (RAA). The primary endpoint is the occurrence of AF episodes lasting ≥6 minutes, as detected by device or surface electrocardiogram. Patients will be followed for up to 24 months.
Eligibility criteria
Qualifiers
Age ≥18 years
Symptomatic sinus bradycardia
Tachy-brady syndrome
Chronotropic incompetence
Disqualifiers
Persistent atrial fibrillation (AF) (>7 days), long-standing persistent AF, permanent AF, or prior atrioventricular node ablation
Prior cardiac implantable electronic device (CIED) requiring replacement, upgrade, or revision
Indication for cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT-D)
Prior cardiac surgery, severe hepatic or renal dysfunction, or other life-threatening systemic diseases
Trial design
Treatments tested in this trial
- RAA pacing
- PSB pacing
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov