Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices

NCT06371846 | Recruiting

• 1 other identifier: 2023 /10850/I
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. The objective of the study consist of assessing if LBBAP criteria, specifically septal and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the 'conventional' signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure. Methods: Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention.

Conditions

Conduction Disorder; Pacemaker DDD

Keywords

Conduction Pacing System; Program System Analyzers

Outcome Measures

Primary Outcomes (1)

• Similarity of signals between multichannel recording system and Pacing System Analyzers

  To describe the similarity of signals between multichannel recording system and Pacing System Analyzers

  First 24 hours

Secondary Outcomes (1)

• Security

  First 24 hours

Study Arms (1)

Cohort one

This was a non-randomized, prospective multicentric study. From july 2023 to may 2024 consecutive patients over 18 years of age who underwent a LBBAP system as first intention, were enrolled from five participating hospitals. Baseline characteristics including demography, pacing indication, basal QRS and left ventricular ejection fraction were collected. For the implantation procedure analysis, total procedural time, total fluoroscopy time, total radiation dosage, pacing electrocardiogram parameters including the paced QRS morphology and duration, V6 R wave peak time (V6-RWPT), and changes between selective and non-selective LBBP were recorded, as well as the pacing lead parameters including R-wave amplitude, threshold and impedance with unipolar and bipolar configurations. First 24hs complications were all documented.

Other: Selected signals from Pacing System Analyzers

Interventions

Selected signals from Pacing System Analyzers OTHER

Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention.

Cohort one

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years of age who underwent a left bundle branch area pacing system as first intention

You may qualify if:

• patients over 18 years of age who underwent a LBBAP system as first intention.

You may not qualify if:

• None

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Jesus Jiménez López

Barcelona, Catalonia, 08005, Spain

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesus Jiménez López, MD

  Cardiac Electrophysiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesus Jiménez López, MD

CONTACT

680714927; jejilo78@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 17, 2024
• Study Start: March 14, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)