Clinical trial NCT04749836: Outcomes and Safety of Various Conduction System Pacing Methods
Official title: Registry of His Bundle, Bachmann Bundle and Left Bundle Branch Area Pacing for Various Pacing Indications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AV Block
Bundle-Branch Block
Atrial Fibrillation Rapid
Keywords: His bundle pacing
Left bundle branch area pacing
Bachmann bundle pacing
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers with pacing indication as described in eligibility criteria.

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.

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

Primary outcomes:
measure: Acute and long-term implant success rate
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Pacing parameters
timeFrame: peri-procedural
measure: Stepwise approach of pacing modes
timeFrame: peri-procedural
measure: Pacing lead stability
timeFrame: through study completion, an average of 2 years
measure: Heart failure hospitalisation
timeFrame: through study completion, an average of 2 years
measure: Echocardiographic measurements
timeFrame: through study completion, an average of 1 year
measure: Procedural characteristics
timeFrame: peri-procedural
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana - Cardiology department
Study officials:
affiliation: University Medical Centre Ljubljana
name: David Žižek, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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