Clinical trial NCT06922526: Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes
Official title: Predictors of Tricuspid Regurgitation Progression and Adverse Outcomes in Different Pacing Modes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Pacemaker
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after cardiac pacemaker implantation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tricuspid regurgitation progression（Progression of tricuspid regurgitation ≥ grade 0.5）
timeFrame: Mean follow-up of 1 year
Secondary outcomes:
measure: Heart Failure Readmission Rate After CIED Implantation
timeFrame: Mean follow-up of 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
Study officials:
affiliation: Shandong First Medical University
name: Haiyan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21.
citation: Li X, Fan X, Wang Q, Wang Z, Zhu H, Li H, Wang H, Liu Z, Yao Y. Tricuspid regurgitation following pacemaker implantation for bradycardia: a two-year study comparing different pacing strategies. Chin Med J (Engl). 2023 Oct 20;136(20):2508-2510. doi: 10.1097/CM9.0000000000002825. Epub 2023 Aug 31. No abstract available.
citation: Li X, Zhu H, Fan X, Wang Q, Wang Z, Li H, Tao J, Wang H, Liu Z, Yao Y. Tricuspid regurgitation outcomes in left bundle branch area pacing and comparison with right ventricular septal pacing. Heart Rhythm. 2022 Jul;19(7):1202-1203. doi: 10.1016/j.hrthm.2022.03.005. Epub 2022 Mar 10. No abstract available.