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Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06922526
Enrollment
200
Registered
2025-04-10
Start date
2025-04-30
Completion date
2026-05-31
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker, Tricuspid Regurgitation

Brief 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.

Interventions

DEVICEPacemaker implantation

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

Sponsors

Haiyan Wang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tricuspid regurgitation progression(Progression of tricuspid regurgitation ≥ grade 0.5)Mean follow-up of 1 yearGrading of tricuspid regurgitation severity:Grade 0: None Grade 0.5: Trace Grade 1: Mild Grade 1.5: Mild to moderate Grade 2: Moderate Grade 2.5: Moderate to severe Grade 3: Severe

Secondary

MeasureTime frame
Heart Failure Readmission Rate After CIED ImplantationMean follow-up of 1 year

Countries

China

Contacts

Primary ContactHaiyan Wang, MD
wanghaiyan96@126.com86-13583184107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026