Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

NCT06922526 | Recruiting

• 1 other identifier: SDYWZGKCJH2024030
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Regurgitation; Pacemaker

Outcome Measures

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

  Mean follow-up of 1 year

Secondary Outcomes (1)

• Heart Failure Readmission Rate After CIED Implantation

  Mean follow-up of 1 year

Study Arms (5)

Right ventricular pacing group

Device: Pacemaker implantation

conduction system pacing group

Device: Pacemaker implantation

biventricular pacing group

Device: Pacemaker implantation

TR progression group

non-TR progression group

Interventions

Pacemaker implantation DEVICE

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

Right ventricular pacing group; biventricular pacing group; conduction system pacing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after cardiac pacemaker implantation

You may qualify if:

• Adult patients
• Patients with an implantable electronic heart device (CIEDs)
• The patient underwent pacemaker implantation at Qianfoshan Hospital between 2015 and 2025

You may not qualify if:

• 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

Sponsors & Collaborators

• Haiyan Wang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, 250000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 24449717 BACKGROUND

• 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.

  PMID: 37649400 BACKGROUND

• 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.

  PMID: 35278699 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Haiyan Wang, MD

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiyan Wang, MD

CONTACT

86-13583184107; wanghaiyan96@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)