Outcomes and Safety of Various Conduction System Pacing Methods

January 6, 2024 updated by: David Žižek, MD, PhD, University Medical Centre Ljubljana

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • University Medical Centre Ljubljana - Cardiology department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All comers with pacing indication as described in eligibility criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: David Žižek, Assist. Prof., University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Conduction pacing Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bundle-Branch Block

Clinical Trials on His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe