NCT06922526

Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Haiyan Wang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tricuspid Regurgitation
• Pacemaker

Interventions

Type	Name	Description
DEVICE	Pacemaker implantation	Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-04-10
• Last updated: 2025-04-30

Locations

1 site across 1 country: China