Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication

Not Applicable

Recruiting

• Conditions: Leadless Pacemaker

• Registration Number: NCT06692218
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.

This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Patients who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
• Patients with ability to provide informed consent

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Exclusion Criteria

• Patients who cannot provide informed consent
• Patient < 18 years old
• Pregnant patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Location of leadless pacemaker implantation	From date of enrollment to date of CT or echocardiogram, up to 1 year	Determine the exact location of leadless pacemaker implantation

Secondary Outcome Measures

Name	Time	Method
Implant location prediction with electrical parameters	From date of enrollment to date of CT or echocardiogram, up to 1 year	Correlate leadless pacemaker electrical parameters (including electrogram characteristics, pacing threshold and sensing) to leadless pacemaker implant position (septal, apex or free wall).

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong