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

NCT07250529 | Recruiting

• 1 other identifier: UHP-LBBP-AHRE-2025
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Pacemaker Therapy; Atrioventricular Block; Preserved Ejection Fraction

Keywords

Left bundle branch pacing; Cardiac electrophysiology; Right ventricular pacing; AHRE burden; Preserved ejection fraction; Heart Failure; Quality of life; Pacing-induced cardiomyopathy (PICM)

Outcome Measures

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.

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

Secondary Outcomes (18)

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

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

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

  From pacemaker implantation (or randomization) to 24 months

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

  From pacemaker implantation (or randomization) to 24 months

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

  From pacemaker implantation (or randomization) to 24 months

• Time to event - for AHRE episodes > 6 min

  From pacemaker implantation (or randomization) to 24 months

Study Arms (2)

Arm 1: Conventional Right Ventricular Pacing

ACTIVE COMPARATOR

Procedure: Standard right ventricular septal pacing Description: 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.

Device: Right Ventricular Pacing

Arm 2: Left Bundle Branch Pacing (LBBP)

ACTIVE COMPARATOR

Procedure: Left bundle branch pacing lead implantation Description: 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.

Device: Left Bundle Branch Pacing

Interventions

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.

Arm 1: Conventional Right Ventricular Pacing

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.

Arm 2: Left Bundle Branch Pacing (LBBP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Scheduled implantation of a dual-chamber pacemaker for:
• Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
• Documented preserved LVEF (≥50%)
• Sinus rhythm at baseline
• Ability to provide written informed consent

You may not qualify if:

• History of paroxysmal, persistent, or permanent atrial fibrillation
• Previous atrial fibrillation ablation (catheter-based or surgical)
• LVEF \< 50%
• Sinus node disease
• Transient AV block requiring pacemaker implantation
• Significant structural or valvular heart disease
• Requirement for pacemaker system upgrade during the study period
• Requirement for antiarrhythmic therapy for causes other than atrial fibrillation
• Existing pacemaker or other cardiac device requiring modification for study participation
• Enrollment in another clinical trial that could interfere with study endpoints or pacing parameters
• Contraindication to LBBP or associated lead implantation procedure
• Life expectancy \< 12 months
• Any condition judged by the investigator to compromise participation or the integrity of study data

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University General Hospital of Patras

Pátrai, Greece

RECRUITING

Related Publications (6)

• Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. doi: 10.1093/eurheartj/ehae373.

  PMID: 38953776 RESULT

• Jansson V, Bergfeldt L, Schwieler J, Kenneback G, Rubulis A, Jensen SM, Raatikainen P, Sciaraffia E, Blomstrom-Lundqvist C. Atrial fibrillation burden, episode duration and frequency in relation to quality of life in patients with implantable cardiac monitor. Int J Cardiol Heart Vasc. 2021 May 11;34:100791. doi: 10.1016/j.ijcha.2021.100791. eCollection 2021 Jun.

  PMID: 34036145 RESULT

• Rosner GF, Reiffel JA, Hickey K. The Concept of "Burden" in Atrial Fibrillation. J Atr Fibrillation. 2012 Feb 2;4(5):400. doi: 10.4022/jafib.400. eCollection 2012 Feb-Mar.

  PMID: 28496712 RESULT

• Boriani G, Tartaglia E, Trapanese P, Tritto F, Gerra L, Bonini N, Vitolo M, Imberti JF, Mei DA. Subclinical atrial fibrillation/atrial high-rate episodes: what significance and decision-making? Eur Heart J Suppl. 2025 Feb 19;27(Suppl 1):i162-i166. doi: 10.1093/eurheartjsupp/suae088. eCollection 2025 Feb.

  PMID: 39980773 RESULT

• Simu G, Rosu R, Cismaru G, Puiu M, Gusetu G, Minciuna I, Istratoaie S, Tomoaia R, Zdrenghea D, Pop D. Atrial high-rate episodes: a comprehensive review. Cardiovasc J Afr. 2021 Mar-Apr 23;32(2):102-107. doi: 10.5830/CVJA-2020-052. Epub 2021 Jan 15.

  PMID: 33496721 RESULT

• AlTurki A, Essebag V. Atrial Fibrillation Burden: Impact on Stroke Risk and Beyond. Medicina (Kaunas). 2024 Mar 26;60(4):536. doi: 10.3390/medicina60040536.

  PMID: 38674182 RESULT

Related Links

• Groundbreaking consensus statement on conduction system pacing released: a major milestone in the evolution of pacing therapy

MeSH Terms

Conditions

Atrial Fibrillation; Atrioventricular Block; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Central Study Contacts

GEORGIOS LEVENTOPOULOS

CONTACT

+306977786020; levent2669@gmail.com

Periklis Davlouros

CONTACT

+306986726300; pdav@upatras.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology - Electrophysiology Patras University Hospital, Greece

Model Details: The primary hypothesis of the study is that left bundle branch pacing is superior to right ventricular pacing with respect to atrial high-rate episode (AHRE) burden, defined as the cumulative duration of all device-detected AHREs with individual episode duration \>6 minutes from implantation to 24 months (atrial rate threshold ≥170 bpm). Because cumulative AHRE time is expected to be highly right-skewed with a substantial proportion of zero values, the primary endpoint will be analyzed using a prespecified two-part hurdle modeling approach, with the transformed continuous component defined as Y = ln(1 + cumulative AHRE minutes). For sample size determination, a pragmatic design-stage approximation was used based on a two-sample comparison of means on the transformed scale Y. This approach was selected because internal pilot data were available for Y and because closed-form sample size procedures for two-part hurdle models require specification of distributional parameters for both the z

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): April 20, 2029
• Study Completion (Estimated): June 20, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

GR (1)