Actively Recruiting
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Led by Chinese University of Hong Kong · Updated on 2024-11-18
196
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying leadless pacemakers, which are implanted entirely inside the heart and avoid some problems seen with traditional pacemakers that have leads going through veins. This study focuses on where the leadless pacemaker attaches inside the right ventricle, especially looking at cases where the device is attached to the free wall of the right ventricle instead of the usual septal area. The goal is to learn if the extra effort to place the device on the septum is necessary by reviewing outcomes in patients with different implant locations. The study also explores if electrical signals recorded during implantation can predict the device position to help guide future procedures. Participants include patients who have already received or will receive a leadless pacemaker starting from January 2015. After implantation, patients will undergo a special non-contrast, ECG-gated CT scan of the heart timed at the end of the heart's relaxation phase to create 3D images that show the exact pacemaker attachment site. This will help determine where the device is located inside the right ventricle. Data from medical records, including demographics, medical history, lab tests, pacemaker electrical data, and medication use before and after implantation, will be collected for analysis. Participants will be invited for the heart CT scan after implantation, with the scan used to confirm the pacemaker's location. Researchers will review the implant location and electrical data to study correlations. The main outcome measured is the implant location from enrollment to the CT scan within one year. Secondary outcomes include predicting implant location from electrical parameters. The study will monitor participants up to one year from enrollment to collect these data. Safety and complications related to implant location will be assessed through this follow-up.
CONDITIONS
Brief Title
Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015
- Patients with ability to provide informed consent
You will not qualify if you...
- Patients who cannot provide informed consent
- Patient < 18 years old
- Pregnant patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year from enrollment to CT or echocardiogram
Participants undergo leadless pacemaker implantation or have already had the implantation since January 2015.
1 visit for non-contrast, ECG-gated CT heart
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
T
Tsz Kin Mark Tam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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