Posterosuperior Bundle Pacing for Prevention of Atrial Fibrillation in Patients With Sinus Node Dysfunction
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
RAA pacing
Procedure/SurgeryAtrial pacing lead implanted at the right atrial appendage. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
PSB pacing
Procedure/SurgeryAtrial pacing lead implanted at the posterosuperior bundle region. Left bundle branch area pacing will be applied if ventricular pacing is necessary.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: PSB pacingExperimental treatment 1 intervention
Group B: RAA pacingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of atrial fibrillation
Incidence of atrial fibrillation ≥ 6 minutes during follow-ups
Time frame
From implantation to regular follow-ups up to 24 monthsSecondary outcomes
1
Atrial high-rate episodes
Time frame
From implantation to regular follow-ups up to 24 months2
AF burden
Time frame
From implantation to regular follow-ups up to 24 months3
Intrinsic P-wave duration
Measured from the onset of the P wave to the end
Time frame
At baseline and regular follow-ups up to 24 months, when intrinsic atrial rhythm is assessable4
Paced P-wave duration
Measured from the pacing stimulus to P wave end duration
Time frame
From implantation to regular follow-ups up to 24 monthsOther outcomes
1
Procedural complications
Safety Outcome
Time frame
Perioperative2
Postoperative adverse events
Safety Outcome, including lead-related complications, thromboembolic events, etc.
Time frame
From implantation to regular follow-ups up to 24 months3
Atrial pacing capture threshold
Time frame
From implantation to regular follow-ups up to 24 months4
Atrial sensing amplitude
Time frame
From implantation to regular follow-ups up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov