Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHaiyan Wang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Patients with an implantable electronic heart device (CIEDs)
The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025
Disqualifiers
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
Trial population
Patients after cardiac pacemaker implantation
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Pacemaker implantation
DevicePacemaker implantation methods include right ventricular pacing, biventricular pacing, conduction system pacing
Treatment groups
200 Participants
are divided into 5 treatment groupsGroup A: Right ventricular pacing group1 intervention
Group B: conduction system pacing group1 intervention
Group C: biventricular pacing group1 intervention
Group D: TR progression group0 interventions
Group E: non-TR progression group0 interventions
Trial outcomes
Primary outcomes
1
Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
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
Time frame
Mean follow-up of 1 yearSecondary outcomes
1
Heart Failure Readmission Rate After CIED Implantation
Time frame
Mean follow-up of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haiyan Wang
Lead sponsor
Qianfoshan Hospital
Sponsor institution
Source ClinicalTrials.gov