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Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion

Recruitingn/aAges 18 Years - anyAllHazem Omran
NCT07342036 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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...) Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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