Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up.
Ulas Höke, Dominique Auger, Joep Thijssen...
https://pubmed.ncbi.nlm.nih.gov/24449717Actively Recruiting
Age: 18Years +
All Genders
ID06922526
Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
Led by Haiyan Wang · Updated on 2025-04-30
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying tricuspid regurgitation (TR), a common complication after implantation of cardiac implantable electronic devices (CIEDs) like pacemakers. Severe TR is linked to higher risks of heart failure hospitalization and death, greatly affecting quality of life. This observational study aims to identify factors predicting worsening TR and adverse outcomes in patients with different pacing methods, to guide care for those at high risk. The study reviews patients who had pacemaker implantation between 2015 and 2025, categorized by pacing type: right ventricular, conduction system, or biventricular pacing. It analyzes TR progression defined as an increase of at least half a grade. Assessments include 3D echocardiography to understand TR mechanisms, fluoroscopic analysis of pacemaker leads, and evaluation of device-related complications like lead dislodgement or infection, along with heart failure readmissions. Participants' data from up to one year of follow-up will be analyzed to measure TR progression and heart failure hospitalizations. The research includes clinical evaluations, imaging studies, and device parameter measurements. This approach helps monitor how pacing modes affect TR and outcomes, aiming to improve management strategies for patients with implanted cardiac devices.
CONDITIONS
Brief Title
Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients
- Patients with an implantable electronic heart device (CIEDs)
- Patients who underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
You will not qualify if you...
- Patients with severe tricuspid regurgitation or prior tricuspid valve surgery or interventional treatment before pacemaker implantation
- Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
- Patients with single-chamber pacemakers or poor imaging quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants undergo pacemaker implantation using one of the pacing methods: right ventricular pacing, conduction system pacing, or biventricular pacing.
1 visit (in-person)
Long-term Monitoring
Duration - Mean follow-up of 1 year
Participants are observed over time to assess tricuspid regurgitation progression and clinical outcomes including heart failure readmission and device-related complications.
Regular follow-up visits during the year as per clinical care
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University
Jinan, China, 250000
Actively Recruiting
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Research Team
H
Haiyan Wang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Published Research Related To This Trial
Tricuspid regurgitation following pacemaker implantation for bradycardia: a two-year study comparing different pacing strategies.
Xiaofei Li, Xiaohan Fan, Qian Wang...
https://pubmed.ncbi.nlm.nih.gov/37649400Tricuspid regurgitation outcomes in left bundle branch area pacing and comparison with right ventricular septal pacing.
Xiaofei Li, Haojie Zhu, Xiaohan Fan...
https://pubmed.ncbi.nlm.nih.gov/35278699