Clinical trial NCT06692218: Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Official title: Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leadless Pacemaker
Keywords: Leadless pacemaker
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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 \&lt; 18 years old
* Pregnant patients

Primary outcomes:
measure: Location of leadless pacemaker implantation
timeFrame: From date of enrollment to date of CT or echocardiogram, up to 1 year
Secondary outcomes:
measure: Implant location prediction with electrical parameters
timeFrame: From date of enrollment to date of CT or echocardiogram, up to 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: