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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.
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.
Device Algorithm Specificity: AHREs will be validated by reviewing the stored atrial electrograms (EGMs) for a random sample of at least 20% of detected episodes to confirm atrial origin, exclude oversensing, and differentiate atrial tachycardia from atrial fibrillation-like episodes. Device model-specific detection thresholds, including refractory oversensing behavior, atrial blanking periods, and sensitivity parameters, will be documented and standardized across participants where possible.
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).
LBBP produces a narrower paced QRS, shorter left ventricular activation time, and more synchronous ventricular contraction compared with RV pacing. These electrophysiologic differences may reduce atrial stretch, left atrial pressure, and atrial substrate remodeling, which are mechanisms believed to lower AHRE burden.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Permanent complete heart block Permanent second-degree AV block (Mobitz II or Mobitz I)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GEORGIOS LEVENTOPOULOS | Contact | +306977786020 | levent2669@gmail.com | |
| Periklis Davlouros | Contact | +306986726300 | pdav@upatras.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Patras | Recruiting | Pátrai | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38953776 | Result | 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. | |
| 34036145 | 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. |
| Label | URL |
|---|---|
| Groundbreaking consensus statement on conduction system pacing released: a major milestone in the evolution of pacing therapy | View source |
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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
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| 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. |
|
| 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 |
| Incidence of progression to clinically documented atrial fibrillation (paroxysmal or persistent, symptomatic or asymptomatic, confirmed by ECG, Holter, or wearable monitoring). | From pacemaker implantation (or randomization) to 24 months |
| Time to first clinically documented atrial fibrillation. | From pacemaker implantation (or randomization) to 24 months |
| Development of permanent atrial fibrillation. | Atrial fibrillation (AF) will be evaluated using routine interrogation of implanted pacemakers, which provide device-recorded atrial arrhythmia data, including AF burden and episode duration. Permanent atrial fibrillation will be defined according to the ESC Guidelines for Atrial Fibrillation and will require a consensus decision between the treating physician and the patient that the arrhythmia is ongoing. This consensus will also include an agreement to pursue a rate-control strategy with no further attempts to restore or maintain sinus rhythm. | From pacemaker implantation (or randomization) to 24 months |
| Time to progression to permanent atrial fibrillation. | From pacemaker implantation (or randomization) to 24 months |
| Device- or procedure-related complications (e.g., cardiac perforation, pericardial tamponade, pneumothorax, hemothorax, infection requiring antibiotics or system removal, generator or lead malfunction, hematoma). | From pacemaker implantation (or randomization) to 24 months |
| All-cause mortality. | From pacemaker implantation (or randomization) to 24 months |
| Hospitalization due to AF | From pacemaker implantation (or randomization) to 24 months |
| Hospitalization due to HF | From pacemaker implantation (or randomization) to 24 months |
| Need for cardioversion. | From pacemaker implantation (or randomization) to 24 months |
| Development of pacing-induced cardiomyopathy (PICM) | Defined as a drop in LVEF of at least 10 percentage points resulting in LVEF <50%, or a relative reduction in global longitudinal strain of at least 15% | From pacemaker implantation (or randomization) to 24 months |
| Changes in biomarkers associated with myocardial stress, inflammation, or injury | NT-proBNP, hsCRP, and troponin | At baseline and at 12 and 24 months, where available. |
| Changes in structured echocardiographic parameters | Including left atrial strain, left atrial volume index, interventricular mechanical delay, left ventricular mechanical delay, and global longitudinal strain, in participants with available echocardiographic studies from centers able to perform these measurements. | At baseline and at 12 and 24 months, where available. |
| Quality-of-life change assessed using a validated questionnaire during follow-up. | Minnesota living with heart-failure questionnaire | At baseline and at 3,6,12,18 and 24 months |
| 28496712 | 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. |
| 39980773 | 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. |
| 33496721 | 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. |
| 38674182 | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D054537 | Atrioventricular Block |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
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