Outcomes and Safety of Various Conduction System Pacing Methods

Recruiting

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

• Registration Number: NCT04749836
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-06
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Heart failure hospitalisation	through study completion, an average of 2 years	Incidence of heart failure hospitalizations after device implantation
Pacing parameters	peri-procedural	Capture threshold, R waves, lead impedance, QRS morphology
Pacing lead stability	through study completion, an average of 2 years	Lead threshold fluctuation
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
Stepwise approach of pacing modes	peri-procedural	Proportion of patients with HBP as a first option and LBBA as a fist option

Trial Locations

Locations (1)

University Medical Centre Ljubljana - Cardiology department; 🇸🇮 Ljubljana, Slovenia