Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational project will enroll adults scheduled for first-time transvenous pacemaker, ICD, or CRT implantation and perform detailed transthoracic echocardiography with 3D tricuspid imaging before and after device placement. Participants will have routine follow-ups at 6 and 12 months with repeat TTE, ECG, NT-proBNP measurement, and device checks to document any change in tricuspid regurgitation. The primary outcome is the incidence of newly developed or worsened TR (greater than trace or increase by at least one grade), and secondary analyses will explore predictors of TR progression. Results aim to clarify how often and when lead-associated TR occurs and which factors increase risk.

Why it matters

Who can join: the full rules

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

Where it's running

• Herz- und Diabeteszentrum NRW
  Bad Oeynhausen, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Principal investigator: Hazem Omran, MD — Herz- und Diabeteszentrum NRW
• Study coordinator: Hazem Omran, MD
• Email: homran@hdz-nrw.de
• Phone: +49 5731 970

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• TruGamma tricuspid valve replacement for high-risk patients

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• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.