Atrial Fibrillation (AF)LBBP-AHRENCT07250529
Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF
A study testing Right Ventricular Pacing and Left Bundle Branch Pacing in people with Atrial Fibrillation (AF) and Pacemaker Therapy, run by University Hospital of Patras at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block
- What is being tested?
- Right Ventricular Pacing and Left Bundle Branch Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteGreece
- Study dates
- 5 Feb 2026to 20 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University General Hospital of Patras
Pátrai
Georgios Leventopoulos, +306977786020, levent2669@gmail.com
About this study
Official title: Comparison of Left Bundle Branch Pacing Versus Conventional Right Ventricular Pacing on AHRE Burden in Patients With Preserved Left Ventricular Ejection Fraction and High Ventricular Pacing Dependency (LBBP-AHRE Trial): A Randomized Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation (AF), Pacemaker Therapy, Atrioventricular Block, Preserved Ejection Fraction
- Being tested
- Right Ventricular Pacing, Left Bundle Branch Pacing
- Keywords
- Left bundle branch pacing, Cardiac electrophysiology, Right ventricular pacing, AHRE burden, Preserved ejection fraction, Heart Failure, Quality of life, Pacing-induced cardiomyopathy (PICM)
- Medical subject headings
- Atrial Fibrillation, Atrioventricular Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Ventricular PacingDevice
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 PacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Left Bundle Branch Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From pacemaker implantation (or randomization) to 24 months
Total cumulative time in AHRE episodes with individual episode duration 6 hours to 24 hours.
Measured: From pacemaker implantation (or randomization) to 24 months
Total cumulative time in AHRE episodes with individual episode duration >24 hours.
Measured: From pacemaker implantation (or randomization) to 24 months
Time to event - for AHRE episodes > 6 min
Measured: 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).
Measured: From pacemaker implantation (or randomization) to 24 months
Time to first clinically documented atrial fibrillation.
Measured: 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.
Measured: From pacemaker implantation (or randomization) to 24 months
Time to progression to permanent atrial fibrillation.
Measured: 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).
Measured: From pacemaker implantation (or randomization) to 24 months
All-cause mortality.
Measured: From pacemaker implantation (or randomization) to 24 months
Hospitalization due to AF
Measured: From pacemaker implantation (or randomization) to 24 months
Hospitalization due to HF
Measured: From pacemaker implantation (or randomization) to 24 months
Need for cardioversion.
Measured: 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%
Measured: From pacemaker implantation (or randomization) to 24 months
Changes in biomarkers associated with myocardial stress, inflammation, or injury
NT-proBNP, hsCRP, and troponin
Measured: 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.
Measured: 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
Measured: At baseline and at 3,6,12,18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start5 Feb 2026
- Primary completion20 Apr 2029 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Leventopoulos, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250529
- Sponsor's protocol ID
- UHP-LBBP-AHRE-2025
- Acronym
- LBBP-AHRE
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38953776Jansson 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.
PubMed 34036145Rosner 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.
PubMed 28496712Boriani 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.
PubMed 39980773Simu 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.
PubMed 33496721AlTurki A, Essebag V. Atrial Fibrillation Burden: Impact on Stroke Risk and Beyond. Medicina (Kaunas). 2024 Mar 26;60(4):536. doi: 10.3390/medicina60040536.
PubMed 38674182
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Left Bundle Branch Pacing Versus Conventional Right Ventricular Pacing on AHRE Burden in Patients With Preserved Left Ventricular Ejection Fraction and High Ventricular Pacing Dependency (LBBP-AHRE Trial): A Randomized Study
- ClinicalTrials.gov ID
- NCT07250529
- Acronym / sponsor ID
- LBBP-AHRE / UHP-LBBP-AHRE-2025
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 20 Apr 2029 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Conventional Right Ventricular Pacing | Active comparator | Device: Right Ventricular PacingProcedure: 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. |
| Arm 2: Left Bundle Branch Pacing (LBBP) | Active comparator | Device: Left Bundle Branch PacingProcedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Ventricular PacingImplantation 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. | Device | Arm 1: Conventional Right Ventricular Pacing |
| Left Bundle Branch PacingImplantation 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. | Device | Arm 2: Left Bundle Branch Pacing (LBBP) |
Primary outcome
Total cumulative AHRE time for device-detected episodes lasting >6 minutes
Time frame: From pacemaker implantation (or randomization) to 24 months (primary endpoint)
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.
18 secondary outcomes
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)
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
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
Total cumulative time in AHRE episodes with individual episode duration >24 hours.
Time frame: From pacemaker implantation (or randomization) to 24 months
Time to event - for AHRE episodes > 6 min
Time frame: 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).
Time frame: From pacemaker implantation (or randomization) to 24 months
Time to first clinically documented atrial fibrillation.
Time frame: From pacemaker implantation (or randomization) to 24 months
Development of permanent atrial fibrillation.
Time frame: From pacemaker implantation (or randomization) to 24 months
Time to progression to permanent atrial fibrillation.
Time frame: 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).
Time frame: From pacemaker implantation (or randomization) to 24 months
All-cause mortality.
Time frame: From pacemaker implantation (or randomization) to 24 months
Hospitalization due to AF
Time frame: From pacemaker implantation (or randomization) to 24 months
Hospitalization due to HF
Time frame: From pacemaker implantation (or randomization) to 24 months
Need for cardioversion.
Time frame: From pacemaker implantation (or randomization) to 24 months
Development of pacing-induced cardiomyopathy (PICM)
Time frame: From pacemaker implantation (or randomization) to 24 months
Changes in biomarkers associated with myocardial stress, inflammation, or injury
Time frame: At baseline and at 12 and 24 months, where available.
Changes in structured echocardiographic parameters
Time frame: At baseline and at 12 and 24 months, where available.
Quality-of-life change assessed using a validated questionnaire during follow-up.
Time frame: At baseline and at 3,6,12,18 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 38953776Becher 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.
- Results publication: PubMed 34036145Jansson 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.
- Results publication: PubMed 28496712Rosner 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.
- Results publication: PubMed 39980773Boriani 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.
- Results publication: PubMed 33496721Simu 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.
- Results publication: PubMed 38674182AlTurki A, Essebag V. Atrial Fibrillation Burden: Impact on Stroke Risk and Beyond. Medicina (Kaunas). 2024 Mar 26;60(4):536. doi: 10.3390/medicina60040536.
- Groundbreaking consensus statement on conduction system pacing released: a major milestone in the evolution of pacing therapyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Ventricular Pacing and Left Bundle Branch Pacing in people with Atrial Fibrillation (AF) and Pacemaker Therapy, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GEORGIOS LEVENTOPOULOS (+306977786020, levent2669@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cumulative AHRE time for device-detected episodes lasting >6 minutes (time frame: From pacemaker implantation (or randomization) to 24 months (primary endpoint)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250529, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.