University General Hospital of Patras
Pátrai, Achaia, 26500, Greece
NCT Number: NCT07305194
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:
1. BBAP + LBBP (physiological pacing group) 2. Right Atrial Appendage (RAA) pacing + LBBP 3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, >24 h), differentiating subclinical AHRE from clinically documented AF.
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Pátrai, Achaia, 26500, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 months
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
Device-detected AHRE episodes lasting 0-6 minutes. Unit of measure: Number of episodes
Time frame: 24 months
Device-detected AHRE episodes lasting 6 minutes to 24 hours. Unit of Measure: Number of episodes
Time frame: 24 months
Device-detected AHRE episodes lasting more than 24 hours. Unit of measure: Number of episodes
Time frame: 24 months
Clinically confirmed AF episodes identified via ECG or rhythm strip. Unit of measure : number of events
Time frame: Baseline, 24 months
Maximum P-wave duration measured on 12-lead ECG Unit of measure : Milliseconds (ms)
Time frame: Baseline, 24 months
Frontal plane P-wave axis measured on 12-lead ECG Unit of Measure: Degrees
Time frame: Baseline, 24 months
Number of participants requiring initiation or change in antiarrhythmic. Unit of Measure: Number of participants
Contact information is provided by the study sponsor or research team.
University Hospital of Patras
Other
Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.
Acronym: AHRE-BLAST
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