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NCT Number: NCT06692218

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

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).

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Tammy Yeung

CONTACT

[email protected]

35051750

Tsz-Kin Mark Tam

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Leadless Pacemaker

Device

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.

Primary outcomes

  1. Location of leadless pacemaker implantation

    Time frame: From date of enrollment to date of CT or echocardiogram, up to 1 year

    Determine the exact location of leadless pacemaker implantation

Secondary outcomes

  1. Implant location prediction with electrical parameters

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Tsz Kin Mark Tam

CONTACT

[email protected]

852 35051750

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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