Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

April 26, 2025 updated by: Haiyan Wang

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jinan, China, 250000
        • Recruiting
        • The First Affiliated Hospital of Shandong First Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients after cardiac pacemaker implantation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Right ventricular pacing group
Device: Pacemaker implantation
Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
conduction system pacing group
Device: Pacemaker implantation
Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
biventricular pacing group
Device: Pacemaker implantation
Pacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
TR progression group
non-TR progression group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean follow-up of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart Failure Readmission Rate After CIED Implantation
Time Frame: Mean follow-up of 1 year
Mean follow-up of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haiyan Wang

Investigators

  • Principal Investigator: Haiyan Wang, MD, The First Affiliated Hospital of Shandong First Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDYWZGKCJH2024030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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