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
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.
CONDITIONS
Official 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 on enrollment
- No existing transvalvular device (must be first implantation)
- No other diagnosed severe valvular heart disease
- Not previous diagnosis with pre-capillary pulmonary hypertension
- No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...)
You will not qualify if you...
- Patients unable to give consent
- Under the age of 18 years
- Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo >70 mmHg)
- Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment
- Patients who have undergone Lead-explantation
- Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment.
- Previous tricuspid valve surgery
- Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...)
- Pregnant or breastfeeding women
- Life expectancy < 12 months
AI-Screening
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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
CONTACT
L
Lena Riemke-Maw, BSc
CONTACT
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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