NCT06692218 Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
| NCT ID | NCT06692218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Leadless Pacemaker |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 196 participants in total. It began in 2024-08-05 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \< 18 years old * Pregnant patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06692218 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leadless Pacemaker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06692218 currently recruiting?
Yes, NCT06692218 is actively recruiting participants. Contact the research team at marktam@cuhk.edu.hk for enrollment information.
Where is the NCT06692218 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06692218 clinical trial?
NCT06692218 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 196 participants.