Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias.

The study includes a comparative assessment across three patient groups:

1. BBAP + LBBP (physiological pacing group) 2. Right Atrial Appendage (RAA) pacing + LBBP 3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, \>24 h), differentiating subclinical AHRE from clinically documented AF.

Secondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI).

The study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines [15] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).

Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).

Ability to be followed up for at least 24 months after implantation.

Provision of written informed consent to participate in the study.

Disqualifiers

History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.

Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).

Inability to comply with long-term follow-up or non-adherence to follow-up visits.

Contraindications to pacemaker lead placement at the selected sites.

Trial population

Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \[15\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

460 Participants
are grouped into 3 trial groups
Group A: Concurrent BBAP + LBBP (total physiological pacing)
Group B: RAA pacing + LBBP
Group C: Conventional pacing (RAA + RV pacing)

Trial outcomes

Primary outcomes

1

AHRE burden

PRIMARY OUTCOME MEASURE Unit of measure : percent (%) AHRE Burden (% of monitored time) Percentage of total monitored time spent in device-detected atrial high-rate episodes (AHRE), as defined by manufacturer diagnostic criteria

Time frame
24 months

Secondary outcomes

1

Number of AHRE episodes (0-6 minutes )

Device-detected AHRE episodes lasting 0-6 minutes. Unit of measure: Number of episodes

Time frame
24 months
2

Number of AHRE Episodes (6 minutes-24 hours)

Device-detected AHRE episodes lasting 6 minutes to 24 hours. Unit of Measure: Number of episodes

Time frame
24 months
3

Number of AHRE Episodes (>24 hours)

Device-detected AHRE episodes lasting more than 24 hours. Unit of measure: Number of episodes

Time frame
24 months
4

Incidence of Clinically Documented Atrial Fibrillation

Clinically confirmed AF episodes identified via ECG or rhythm strip. Unit of measure : number of events

Time frame
24 months

Other outcomes

Sponsors and contacts

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