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NCT Number: NCT06922526

Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

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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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pacemaker Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Shandong First Medical University

Jinan, 250000, China

Location status: Recruiting

Location contact

Haiyan Wang, MD

CONTACT

[email protected]

86-13583184107

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacemaker implantation

Device

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

Primary outcomes

  1. Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）

    Time frame: Mean follow-up of 1 year

    Grading 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 outcomes

  1. Heart Failure Readmission Rate After CIED Implantation

    Time frame: Mean follow-up of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyan Wang, MD

CONTACT

[email protected]

86-13583184107

Sponsors and collaborators

Lead sponsor

Haiyan Wang

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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