Actively Recruiting
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Led by Hazem Omran · Updated on 2026-01-16
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of new or worsening tricuspid valve regurgitation (TR) in patients receiving a pacemaker or defibrillator with a transvenous lead. This observational study aims to prospectively assess patients undergoing cardiac electronic device implantation to document the frequency and predictive factors of TR development or progression, which has previously been reported mainly in retrospective analyses. The study monitors patients with three types of device leads: standard pacemaker leads, implantable cardioverter defibrillator (ICD) leads, and left bundle branch area pacing (LBBaP) leads. Transthoracic echocardiograms (TTE) including 3D imaging of the tricuspid valve will be performed before and after implantation. Follow-up visits at 6 and 12 months will include TTE, ECG, NT-proBNP blood tests, and device checks to assess heart function and valve condition. Participants will be evaluated through imaging and heart function tests before and after device implantation, with scheduled follow-ups up to one year. The main outcome measured is worsening of TR by at least one grade. Secondary outcomes include TR severity, changes in NT-proBNP levels, and hospitalizations for heart failure. This comprehensive monitoring aims to improve understanding of TR related to device leads and support better patient care.
CONDITIONS
Brief Title
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically indicated for pacemaker, ICD, or CRT implantation
- No previous diagnosis of severe tricuspid regurgitation at enrollment
- No existing transvalvular device; this must be the first implantation
- No other diagnosed severe valvular heart disease
- No previous diagnosis of pre-capillary pulmonary hypertension
- No previous diagnosis of structural disease of the right ventricle such as arrhythmogenic cardiomyopathy, cardiac sarcoidosis, or carcinoid
You will not qualify if you...
- Unable to give consent
- Under 18 years of age
- Relevant pre-capillary pulmonary hypertension as decided by the heart team (sPAP echo >70 mmHg)
- Severe tricuspid valve regurgitation (Grade 3 or worse) at enrollment
- Previous lead explantation
- Existing valvular heart disease requiring treatment as decided by the heart team, although these patients may join after treatment
- Previous tricuspid valve surgery
- Congenital heart disease such as tetralogy of Fallot or Ebstein's anomaly
- Pregnant or breastfeeding women
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo cardiac electronic device implantation and initial assessments to document tricuspid regurgitation status.
1 implantation visit
Duration - Up to 12 months
Participants are monitored for up to 1 year after lead insertion to observe incidence or worsening of tricuspid regurgitation and related clinical outcomes.
Follow-up visits at 6 and 12 months
Trial Site Locations
Total: 1 location
1
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
Research Team
H
Hazem Omran, MD
L
Lena Riemke-Maw, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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