Evaluating tricuspid regurgitation progression in pacemaker patients
Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
This study looks at how tricuspid regurgitation gets worse over time in patients with pacemakers to see if different types of heart pacing affect their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan) |
| Trial ID | NCT06922526 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the progression of tricuspid regurgitation (TR) in patients who have received cardiac implantable electronic devices (CIEDs) over a ten-year period. It analyzes various pacing modalities, including right ventricular, conduction system, and biventricular pacing, to identify predictors of adverse outcomes related to TR. The methodology includes 3D echocardiographic assessments, fluoroscopic analysis of lead parameters, and multivariable regression to evaluate the impact of pacing modes on clinical outcomes and complications. The goal is to provide clinical guidance for high-risk patients experiencing TR.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients who have undergone pacemaker implantation at Qianfoshan Hospital between 2015 and 2025.
Not a fit: Patients with severe tricuspid regurgitation or those who have had prior tricuspid valve surgery or interventional treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with pacemakers, potentially reducing heart failure hospitalizations and mortality rates.
How similar studies have performed: While the study addresses a common complication in pacemaker patients, similar studies have not extensively evaluated the impact of different pacing modalities on TR progression, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients 2. Patients with an implantable electronic heart device (CIEDs) 3. The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025 Exclusion Criteria: 1. Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation 2. Patients with severe valvular heart disease, congenital heart disease, or arrhythmias 3. Patients with single-chamber pacemakers or poor images
Where this trial is running
Jinan
- The First Affiliated Hospital of Shandong First Medical University — Jinan, China (Recruiting)
Study contacts
- Principal investigator: Haiyan Wang, MD — Shandong First Medical University
- Study coordinator: Haiyan Wang, MD
- Email: wanghaiyan96@126.com
- Phone: 86-13583184107
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.