An observational study in Atrial Arrhythmia, Atrial Fibrillation (AF) and Pacemaker Implantation, sponsored by University Hospital of Patras. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by University Hospital of Patras · Observational
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:
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.
Atrial high-rate episodes (AHRE) detected by cardiac implantable devices are associated with an increased risk of developing atrial fibrillation (AF), stroke, and atrial remodeling. Traditional right atrial and right ventricular pacing may alter atrial activation patterns, potentially promoting electrical and structural changes that predispose to atrial arrhythmias.
Physiologic pacing strategies targeting the Bachmann bundle region and the left bundle branch have emerged as alternatives designed to preserve normal conduction pathways. Bachmann Bundle Area Pacing (BBAP) facilitates more synchronous biatrial activation, while Left Bundle Branch Pacing (LBBP) results in near-physiologic ventricular activation. Both methods may reduce conduction delays and improve atrial and ventricular electromechanical function.
This prospective observational study examines whether physiologic atrial and ventricular pacing reduces the burden of device-detected AHRE compared with commonly used pacing configurations. Three groups are evaluated: (1) BBAP combined with LBBP, (2) right atrial appendage pacing combined with LBBP, and (3) conventional right atrial and right ventricular pacing. All enrolled participants have a clinical indication for permanent pacing and no prior diagnosis of AF.
AHRE burden will be assessed through routine device diagnostics and remote monitoring over a 24-month follow-up. Electrocardiographic and echocardiographic data will also be collected to explore relationships between conduction patterns, atrial function, and arrhythmia occurrence. The study aims to clarify whether preserving physiologic conduction pathways influences long-term AHRE burden and may contribute to AF prevention in paced patients.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 460 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University Hospital of Patras is the lead sponsor of 43 studies on the registry; 11 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Maximum P-Wave Duration
Maximum P-wave duration measured on 12-lead ECG Unit of measure : Milliseconds (ms)
Time frame: Baseline, 24 months
P - wave axis
Frontal plane P-wave axis measured on 12-lead ECG Unit of Measure: Degrees
Time frame: Baseline, 24 months
Initiation or Modification of Antiarrhythmic Therapy
Number of participants requiring initiation or change in antiarrhythmic. Unit of Measure: Number of participants
Time frame: Baseline, 24 months
Plan to share: Undecided
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital of Patras