Registry for treating severe tricuspid valve issues

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 multicenter observational study focuses on patients with severe tricuspid regurgitation who are undergoing interventional treatment. It aims to analyze the success and safety of various interventional repair techniques for this condition, which is often associated with significant morbidity and mortality. Clinical, echocardiographic, and laboratory parameters will be collected to evaluate the outcomes of these treatments. The study is designed to provide insights into alternative treatment options for patients who are not eligible for surgical repair due to high mortality risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
* Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.

Exclusion Criteria:

* No agreement to participation
* Age \< 18 years

Where it's running

• Klinikum der LMU Muenchen
  Munich, Germany Recruiting

Study contacts

• Principal investigator: Jörg Hausleiter, MD — Klinikum der LMU Muenchen
• Study coordinator: Jörg Hausleiter, MD
• Email: joerg.hausleiter@med.uni-muenchen.de
• Phone: +49 89 4400 72361

Similar studies

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

• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

  This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.

  Recruiting Robert Bosch Medical Center · Stuttgart · NCT07464106

• Evaluating the DUO System for treating Tricuspid Regurgitation

  This study is testing a new heart valve system to see if it can help people with severe tricuspid regurgitation feel better and improve their heart function.

  Recruiting at 17 sites CroiValve Limited · Phoenix, Arizona and 17 other locations · NCT05913908

• Follow-up of patients treated with TricValve® for heart valve issues

  This study follows patients who have had treatment for severe tricuspid regurgitation using the TricValve® system to see how well the valve is working over the next five years.

  Recruiting at 12 sites P+F Products + Features GmbH · Sankt Pölten, Lower Austria and 27 other locations · NCT05114850

• Transcatheter valve repair for severe tricuspid regurgitation

  This study is testing a new valve repair system to see if it helps people with severe tricuspid regurgitation feel better compared to just taking their medications.

  Recruiting at 45 sites Edwards Lifesciences · Phoenix, Arizona and 78 other locations · NCT04097145

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

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.