Outcomes and Safety of Various Conduction System Pacing Methods

University Medical Centre Ljubljana

Status: Enrolling

Conditions: AV Block; Bundle-Branch Block; Atrial Fibrillation Rapid

Treatments: Procedure: His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing

Study type: Observational

Funder types: Other

Identifiers

NCT04749836

Conduction pacing Registry

Details and patient eligibility

About

The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 5 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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