Investigation of the EVOQUE System for Tricuspid Valve Replacement

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 evaluate the safety and clinical efficacy of the Edwards EVOQUE system for transcatheter tricuspid valve replacement in patients with tricuspid valve regurgitation and other heart valve diseases. Up to 500 patients will be enrolled across 45 sites in Europe, with assessments conducted at baseline, post-procedure, and annually for five years. The study will provide real-world data on the device's performance and patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
2. Patient agrees to attend follow-up assessments.
3. Patients provided written informed consent for participation in the study.

Exclusion Criteria:

1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
2. Any patient considered to be part of a vulnerable population.

Where it's running

• Zentralklinik Bad Berka GmbH
  Bad Berka, Germany Recruiting
• Kerckhoff-Klinik GmbH Bad Nauheim
  Bad Nauheim, Germany Recruiting
• Rhoen-Klinikum Campus - Bad Neustadt
  Bad Neustadt an der Saale, Germany Recruiting
• Herz-und Diabeteszentrum NRW
  Bad Oeynhausen, Germany Recruiting
• Deutsches Herzzentrum der Charité (DHZC)
  Berlin, Germany Recruiting
• Herzzentrum Universitaet Bonn
  Bonn, Germany Recruiting

Study contacts

• Principal investigator: Volker Rudolph, Prof. MD — Herz-und Diabeteszentrum NRW, Bad Oeynhausen
• Study coordinator: TMTT Clinical
• Email: TMTT_Clinical@Edwards.com
• Phone: +1-949-250-2500 or

Similar studies

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

• Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation

  This study is testing a new device to replace the tricuspid valve in adults with severe valve problems to see if it is safe and works well.

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• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• TRIFORMIS RESILIA heart valve real-world results in tricuspid disease

  A real-world, observational study to see how the Edwards TRIFORMIS RESILIA tricuspid heart valve performs in adults needing tricuspid valve replacement.

  Recruiting Edwards Lifesciences · Carmel, Indiana · NCT07684313

• Multimodal Cardiac MRI to See How the Heart Is Working

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  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07617844

• 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.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation

  This study is testing a new device to replace the tricuspid valve in adults with severe regurgitation who can't have traditional surgery to see if it is safe and works well.

  Recruiting at 6 sites TRiCares · Aalst and 7 other locations · NCT06581471

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.