An observational study in AV Block, Bundle-Branch Block and Atrial Fibrillation Rapid, sponsored by University Medical Centre Ljubljana. Recruiting at 1 site in Slovenia. Open to participants aged 5 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by University Medical Centre Ljubljana · Observational
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
In comparison with right ventricular pacing-induced electromechanical dyssynchrony, conduction system pacing is providing physiological pacing via His-Purkinje activation. Current approaches include His bundle (HBP), left bundle branch area pacing (LBBAP), and Bachmann bundle pacing. In addition, HBP and LBBAP enable correction of underlying proximal bundle branch block, consequently improving the ventricular activation time and narrowing the QRS. Furthermore, atrial activation can be improved with direct Bachmann bundle stimulation. However, the data regarding long-term performance and safety of these physiological approaches in various clinical scenarios is scarce.
With this registry, the investigators would like to obtain real-world data regarding the feasibility and safety of this physiological pacing approaches in various pacing indications and their implementation in routine clinical practice.
Implant success rate, specific implant characteristics, procedural complications, electrical parameters and clinical outcomes will be analyzed at implantation, 1-3 months after inclusion and every 6 months thereafter. Minimal follow-up will be 2 years.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 150 is below the median of 300 across 37 observational studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All comers with pacing indication as described in eligibility criteria.
Inclusion Criteria:
Different active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead. Stepwise approach for conduction pacing will also be tested.
Acute and long-term implant success rate
Ventricular activation occurring over the conduction system with acceptable pacing threshold
Time frame: through study completion, an average of 2 years
Pacing parameters
Capture threshold, R waves, lead impedance, QRS morphology
Time frame: peri-procedural
Stepwise approach of pacing modes
Proportion of patients with HBP as a first option and LBBA as a fist option
Time frame: peri-procedural
Pacing lead stability
Lead threshold fluctuation
Time frame: through study completion, an average of 2 years
Heart failure hospitalisation
Incidence of heart failure hospitalizations after device implantation
Time frame: through study completion, an average of 2 years
Echocardiographic measurements
Assessment of cardiac function
Time frame: through study completion, an average of 1 year
Procedural characteristics
Total procedure and fluoroscopy time in minutes
Time frame: peri-procedural
Plan to share: Undecided
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