Evaluating tricuspid valve changes after heart device 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 observational study focuses on patients who are undergoing new implantation of cardiac implantable electronic devices (CIEDs). It aims to assess the prevalence and mechanisms of tricuspid regurgitation (TR) that may develop post-implantation through advanced echocardiographic imaging techniques. The study will track morphological and functional changes in the tricuspid valve and right heart chambers over a period of up to five years, with follow-up assessments at discharge, three months, one year, and annually thereafter. Additionally, it seeks to identify risk factors associated with new or worsening TR following the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Patient able and willing to give informed consent in written form before the index procedure
* Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
* Patients undergoing any new CIED implantation with or without transvalvular lead
* Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers

Exclusion Criteria:

* Previous or present CIED
* Life expectancy \< 12 months due to non-cardiac condition
* Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
* Previous tricuspid valve intervention (transcatheter, surgical)
* Participation in another study, which would lead to deviations from this trial protocol

Where it's running

• San Luca Hospital
  Milan, Mi, Italy Recruiting

Study contacts

• Principal investigator: Luigi Badano, MD, Ph.D. — Istituto Auxologico Italiano, IRCCS
• Study coordinator: Luigi P Badano, MD, Ph.D.
• Email: l.badano@auxologico.it
• Phone: +3902619112319

Similar studies

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

• Leadless pacemaker outcomes and follow-up at University Hospital St. Pölten

  This registry will collect and analyze outcomes and complications in adults who receive leadless pacemakers at University Hospital St. Pölten to see how the devices perform over time.

  Recruiting Karl Landsteiner University of Health Sciences · Sankt Pölten, Lower Austria · NCT07246135

• See if the Doraldo-Castelletti scale helps decide if migraine patients should see a physiotherapist

  This study tests whether a brief cervical screening scale can help neurologists decide which migraine patients might benefit from physiotherapy.

  Recruiting Istituto Auxologico Italiano · Milan · NCT07626307

• MicroRNA and bone markers linked to response to romosozumab and abaloparatide in postmenopausal osteoporosis

  Researchers will test whether microRNA and other bone markers can predict how well postmenopausal women with osteoporosis respond to romosozumab and abaloparatide.

  Recruiting Istituto Auxologico Italiano · Miano, Lombardy and 1 other locations · NCT07616401

• How obesity affects daily activities and physical abilities in older adults

  This study tests how excess weight in people over 65 impacts daily tasks and physical performance, comparing obese seniors to normal-weight peers.

  Recruiting Istituto Auxologico Italiano · Oggebbio · NCT07614464

• Multisensory neuromodulation to improve visual field loss after stroke

  This will try combining audio-visual training with noninvasive brain stimulation (tDCS) to help people within three months of stroke who have homonymous hemianopsia improve their visual field and visual scanning.

  Recruiting Istituto Auxologico Italiano · Milan, Lombardy · NCT07358832

• Longitudinal integrated biomarker profiling linked to ALS clinical features

  This project will test whether repeated blood and spinal-fluid biomarker measurements combined with deep clinical profiling can help predict disease course in adults with ALS.

  Recruiting Istituto Auxologico Italiano · Milan, Lombardy · NCT07312240

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.