Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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

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Tricuspid Regurgitation Pacemaker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Right ventricular pacing group

Pacemaker implantation

Intervention Type DEVICE

Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing

conduction system pacing group

Pacemaker implantation

Intervention Type DEVICE

Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing

biventricular pacing group

Pacemaker implantation

Intervention Type DEVICE

Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing

TR progression group

No interventions assigned to this group

non-TR progression group

No interventions assigned to this group

Interventions

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Pacemaker implantation

Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No