Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pacemaker implantation.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Pacemaker. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
Overview
Tricuspid regurgitation (TR) is a common complication following cardiac implantable electronic device (CIED) implantation, with severe TR being associated with increased rates of heart failure hospitalization and all-cause mortality, significantly impairing patients' quality of life. With technological advancements, physiological pacing modalities have demonstrated superior clinical efficacy and safety profiles compared to conventional pacing methods. This study aims to evaluate predictors of adverse outcomes and TR progression in CIED recipients under different pacing modalities, thereby providing clinical guidance for high-risk patients.
Detailed description
This retrospective study analyzed patients undergoing pacemaker implantation from January 2015 to March 2025, stratified by pacing modality (right ventricular/conduction system/biventricular pacing) and TR progression (worsened \[≥1-grade increase\] vs non-worsened TR).
The protocol included: (1) 3D echocardiographic assessment of TR mechanisms, (2) quantitative fluoroscopic analysis of lead parameters (tension, mobility, angulation), (3) multivariable regression evaluating pacing modes and TR progression on clinical outcomes, and (4) documentation of device-related complications (lead dislodgement/infection) and heart failure rehospitalization.
Interventions
- Device Pacemaker implantation
Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
Primary outcome measures
- Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5） [Time frame: Mean follow-up of 1 year]
Secondary outcome measures (1)
- Heart Failure Readmission Rate After CIED Implantation [Time frame: Mean follow-up of 1 year]
Eligibility criteria
Inclusion criteria
- Adult patients
- Patients with an implantable electronic heart device (CIEDs)
- The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
Exclusion criteria
- Patients with severe tricuspid regurgitation or those who have undergone tricuspid valve surgery or interventional treatment prior to pacemaker implantation
- Patients with severe valvular heart disease, congenital heart disease, or arrhythmias
- Patients with single-chamber pacemakers or poor images
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University — Jinan
Publications
- Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21. PMID 24449717
- Li X, Fan X, Wang Q, Wang Z, Zhu H, Li H, Wang H, Liu Z, Yao Y. Tricuspid regurgitation following pacemaker implantation for bradycardia: a two-year study comparing different pacing strategies. Chin Med J (Engl). 2023 Oct 20;136(20):2508-2510. doi: 10.1097/CM9.0000000000002825. Epub 2023 Aug 31. No abstract available. PMID 37649400
- Li X, Zhu H, Fan X, Wang Q, Wang Z, Li H, Tao J, Wang H, Liu Z, Yao Y. Tricuspid regurgitation outcomes in left bundle branch area pacing and comparison with right ventricular septal pacing. Heart Rhythm. 2022 Jul;19(7):1202-1203. doi: 10.1016/j.hrthm.2022.03.005. Epub 2022 Mar 10. No abstract available. PMID 35278699
Identifiers
NCT: NCT06922526 · SDYWZGKCJH2024030