Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

Haiyan Wang

Status: Enrolling

Conditions: Pacemaker; Tricuspid Regurgitation

Treatments: Device: Pacemaker implantation

Study type: Observational

Funder types: Other

Identifiers

NCT06922526

SDYWZGKCJH2024030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 5 patient groups

Right ventricular pacing group

Treatment:

Device: Pacemaker implantation

conduction system pacing group

Treatment:

Device: Pacemaker implantation

biventricular pacing group

Treatment:

Device: Pacemaker implantation

TR progression group

non-TR progression group