Outcomes and Safety of Various Conduction System Pacing Methods

Study Overview
=================
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.

Official Title
-----------------
Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications

Conditions
-----------------
AV Block, Bundle-Branch Block, Atrial Fibrillation Rapid

Intervention / Treatment
-----------------
* Procedure: His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: His 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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and long-term implant success rate | Ventricular activation occurring over the conduction system with acceptable pacing threshold | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pacing parameters | Capture threshold, R waves, lead impedance, QRS morphology | peri-procedural | 
| Stepwise approach of pacing modes | Proportion of patients with HBP as a first option and LBBA as a fist option | peri-procedural | 
| Pacing lead stability | Lead threshold fluctuation | through study completion, an average of 2 years | 
| Heart failure hospitalisation | Incidence of heart failure hospitalizations after device implantation | through study completion, an average of 2 years | 
| Echocardiographic measurements | Assessment of cardiac function | through study completion, an average of 1 year | 
| Procedural characteristics | Total procedure and fluoroscopy time in minutes | peri-procedural | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
His bundle pacing, Left bundle branch area pacing, Bachmann bundle pacing