Evaluating tricuspid regurgitation progression in pacemaker patients
Official title: Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
Run by Qianfoshan Hospital · NCT06922526 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan) |
| Status | Recruiting |
| Started | April 2025 |
| Main results expected | March 2026 |
| Study ends | May 2026 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT06922526 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult patients who have undergone pacemaker implantation at Qianfoshan Hospital between 2015 and 2025.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
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Higher pacemaker rate for people with cardiac amyloidosis
This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.
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Compare leadless and left bundle branch pacemakers for heart and valve function
This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.
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TriClip for treating tricuspid regurgitation in Japan
This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.
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Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults
This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
-
Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation
This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.