Follow-up of patients treated with TricValve® for heart 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 observational study aims to follow up on patients who have undergone treatment for severe tricuspid regurgitation using the TricValve® Transcatheter Bicaval Valves System. Participants will be monitored over a period of up to five years through regular clinical consultations, which will include routine examinations such as hemograms, renal function tests, electrocardiograms, and echocardiograms. The goal is to assess the functioning and hemodynamic profile of the bioprosthesis after the procedure. The study will enroll subjects based on specific inclusion criteria and will document their health outcomes throughout the follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Successful treatment with TricValve Transcatheter Bicaval Valves System
* Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent

Exclusion Criteria:

* no exclusion criterion

Where it's running

• Parc de Salut Mar
  Barcelona, Spain Recruiting
• Hospital Clinic Barcelona
  Barcelona, Spain Recruiting
• Hospital Universitari Germans Trias i Pujol
  Barcelona, Spain Recruiting
• Hospital Universitario Reina Sofia de Córdoba
  Córdoba, Spain Recruiting
• Hospital Universitario Lucus Augusti
  Lugo, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Ignacio J Amat Santos, Dr — Hospital Clínico Universitario de Valladolid
• Study coordinator: Sandra Scheidl, MSc
• Email: sscheidl@pfcardiovascular.com
• Phone: +436601148208

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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.