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

NCT06692218 | Recruiting FDA Device

• 1 other identifier: Leadless-CT study
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Leadless Pacemaker

Keywords

Leadless pacemaker

Outcome Measures

Primary Outcomes (1)

• Location of leadless pacemaker implantation

  Determine the exact location of leadless pacemaker implantation

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

Secondary Outcomes (1)

• Implant location prediction with electrical parameters

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

Study Arms (1)

CT

OTHER

All patients will have a non-contrast, ECG-gated CT heart to adjudicate implant position of leadless pacemaker.

Device: Leadless pacemaker

Interventions

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.

CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Central Study Contacts

Tsz Kin Mark Tam

CONTACT

852 35051750; marktam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: November 18, 2024
• Study Start: August 5, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-09

Locations

HK (1)