Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of Patras

About this trial

This prospective, randomized controlled trial aims to evaluate the effect of left bundle branch pacing (LBBP) compared with conventional right ventricular (RV) pacing on the cumulative duration (total time) of atrial high-rate episodes (AHREs) in patients with preserved left ventricular ejection fraction (LVEF) who are expected to require frequent ventricular pacing.

Atrial High-Rate Episodes (AHREs) are defined as episodes of atrial tachyarrhythmia that are automatically recorded by device diagnostics and detected by implanted cardiac devices. These episodes usually have an atrial rate ≥170 beats per minute and a duration ≥6 minutes. AHREs are linked to a higher risk of thromboembolic events and clinical atrial fibrillation (AF), and they may indicate subclinical AF or other atrial tachyarrhythmias.

Chronic RV pacing has been linked to mechanical and electrical dyssynchrony, which may encourage atrial remodeling and the development of AF. LBBP provides a more physiological ventricular activation and may reduce atrial tachyarrhythmia time (AHRE time).

Patients with LVEF \>50% and atrioventricular (AV) conduction disorders requiring a dual-chamber pacemaker will be randomized to either conventional RV septal pacing or LBBP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Documented preserved LVEF (≥50%)

Sinus rhythm at baseline

Ability to provide written informed consent

Disqualifiers

History of paroxysmal, persistent, or permanent atrial fibrillation

Previous atrial fibrillation ablation (catheter-based or surgical)

LVEF < 50%

Sinus node disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Right Ventricular Pacing

    Device

    Implantation of a dual-chamber pacemaker with the ventricular lead placed in the RV septum. At follow-up, the ventricular pacing percentage and pacing configuration will be noted. All devices used in this study are commercially available in the European Union and carry a valid CE mark.

  • Left Bundle Branch Pacing

    Device

    Implantation of a dual-chamber pacemaker with the ventricular lead placed at the left bundle branch area. Physiological pacing will be programmed into the devices and, at follow-up, the percentage of spontaneous pacing will be noted. All devices used in this study are commercially available in the European Union and carry a valid CE mark.

Treatment groups

244 Participants
are divided into 2 treatment groups
Group A: Arm 1: Conventional Right Ventricular PacingActive comparator 1 intervention
Group B: Arm 2: Left Bundle Branch Pacing (LBBP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total cumulative AHRE time for device-detected episodes lasting >6 minutes

Sum of the durations of all device-detected AHREs with individual episode duration \>6 minutes (atrial rate threshold per device diagnostics, typically ≥170 bpm), expressed as total time (minutes/hours). Total analyzable monitoring time will be defined as the interval from implantation to the last successful device interrogation/remote transmission, excluding periods of missing device data.

Time frame
From pacemaker implantation (or randomization) to 24 months (primary endpoint)

Secondary outcomes

1

Total cumulative time in AHRE episodes with individual episode duration 0 to 6 minutes.

Time frame
From pacemaker implantation (or randomization) to 24 months (primary endpoint)
2

Total cumulative time in AHRE episodes with individual episode duration 6 minutes to 6 hours.

Time frame
From pacemaker implantation (or randomization) to 24 months
3

Total cumulative time in AHRE episodes with individual episode duration 6 hours to 24 hours.

Time frame
From pacemaker implantation (or randomization) to 24 months
4

Total cumulative time in AHRE episodes with individual episode duration >24 hours.

Time frame
From pacemaker implantation (or randomization) to 24 months

Other outcomes

Sponsors and contacts

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