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

November 14, 2024 updated by: Tam Tsz Kin, Chinese University of Hong Kong

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

196

Phase

  • Not Applicable

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
          • Tsz-Kin Mark Tam

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CT
All patients will have a non-contrast, ECG-gated CT heart to adjudicate implant position of leadless pacemaker.
Device: Leadless pacemaker
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of enrollment to date of CT or echocardiogram, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From date of enrollment to date of CT or echocardiogram, up to 1 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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)

August 5, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Leadless-CT study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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 Leadless Pacemaker

Clinical Trials on Leadless pacemaker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe