Atrial Fibrillation Rapid, AV Block, Bundle-Branch Block
Conditions
Keywords
His bundle pacing, Left bundle branch area pacing, Bachmann bundle pacing
Brief summary
The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.
Detailed description
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.
Interventions
PROCEDUREHis bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing
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.
Sponsors
University Medical Centre Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Class I and II indications for permanent pacing * Atrial fibrillation with uncontrolled ventricular rate for pace and ablate strategy * Bundle branch block correction for HF patients * Patients with prolonged PR interval and dromotropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute and long-term implant success rate | through study completion, an average of 2 years | Ventricular activation occurring over the conduction system with acceptable pacing threshold |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stepwise approach of pacing modes | peri-procedural | Proportion of patients with HBP as a first option and LBBA as a fist option |
| Pacing lead stability | through study completion, an average of 2 years | Lead threshold fluctuation |
| Pacing parameters | peri-procedural | Capture threshold, R waves, lead impedance, QRS morphology |
| Echocardiographic measurements | through study completion, an average of 1 year | Assessment of cardiac function |
| Procedural characteristics | peri-procedural | Total procedure and fluoroscopy time in minutes |
| Heart failure hospitalisation | through study completion, an average of 2 years | Incidence of heart failure hospitalizations after device implantation |
Countries
Slovenia
Contacts
Primary ContactDavid Žižek, Assist. Prof.
Outcome results
None listed