Examining the effectiveness of leadless pacemaker implantation locations
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
NA · Chinese University of Hong Kong · NCT06692218
This study is testing if putting leadless pacemakers in different spots in the heart works just as well and is just as safe for patients as the usual placement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06692218 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the implantation positions of leadless pacemakers and their efficacy and complication rates. It focuses on patients who have received leadless pacemakers, particularly examining cases where the device was implanted in the right ventricular free wall instead of the traditional septal position. By analyzing the outcomes of these patients, the study aims to determine if the emphasis on septal implantation is necessary, especially in populations with smaller heart sizes. The research will utilize intraoperative data to assess the safety and effectiveness of different implantation sites.
Who should consider this trial
Good fit: Ideal candidates include patients who have received or are scheduled to receive a leadless pacemaker since January 1, 2015.
Not a fit: Patients who are under 18 years old, pregnant, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more flexible implantation techniques for leadless pacemakers, improving patient outcomes and reducing complications.
How similar studies have performed: While the approach of examining different implantation sites is relatively novel, previous studies have shown the safety of leadless pacemakers, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Tsz Kin Mark Tam
- Email: marktam@cuhk.edu.hk
- Phone: 852 35051750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leadless Pacemaker, Leadless pacemaker