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

TRICUS REGISTRY - Retrospective Prospective Multicentric Clinical Follow up of Patients With Severe Tricuspid Regurgitation After Being Treated With the TricValve® Transcatheter Bicaval Valves System.

P+F Products + Features GmbH · NCT05114850

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.

Quick facts

Study typeObservational
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorP+F Products + Features GmbH (industry)
Locations28 sites (Sankt Pölten, Lower Austria and 27 other locations)
Trial IDNCT05114850 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have successfully received treatment with the TricValve® Transcatheter Bicaval Valves System.

Not a fit: Patients who have not undergone treatment with the TricValve® system will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the TricValve® system for patients with tricuspid valve issues.

How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown success in monitoring long-term outcomes for transcatheter heart valve interventions.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Sankt Pölten, Lower Austria and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Insufficiency, Heart Failure, Heart Diseases, Heart Valve Diseases, Cardiovascular disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.