TriClip System post-market safety and performance in real-world tricuspid regurgitation patients

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 is a prospective, observational study conducted at up to 100 centers worldwide to confirm the safety and effectiveness of TriClip TEER in real-world use according to approved indications. It enrolls patients undergoing the TriClip procedure and follows them at discharge, 30 days, 6 months (phone), 12 months, and annually for up to 5 years, with an independent echocardiography core lab reviewing imaging. An imaging substudy with up to 250 participants and baseline plus 12-month CT scans will explore reverse cardiac remodeling. The study involves pre-procedure eligibility assessment and informed consent, with ongoing follow-up to capture outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
3. Subject agrees to attend follow-up assessments.
4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent.

Exclusion Criteria:

1. Subject is participating in another clinical study that could impact the follow-up or results of this study.
2. Subject has an existing TriClip implant
3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.

Where it's running

• Banner University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting
• Scripps Health
  La Jolla, California, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• Ascension Alexian Brothers
  Elk Grove, Illinois, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting
• Ascension Texas Cardiovascular Research
  Austin, Texas, United States Recruiting

Study contacts

• Study coordinator: Allison Wood
• Email: allison.wood@abbott.com
• Phone: 612-518-9034

Similar studies

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

• What happens to the tricuspid valve in atrial fibrillation patients without strong valve leakage

  This study looks at how the tricuspid valve changes over a year in people with atrial fibrillation who don’t have significant valve leakage, using 3D heart imaging.

  Recruiting Centro Cardiologico Monzino · Milan, Milan · NCT07617974

• Early rhythm control in atrial fibrillation with tricuspid regurgitation

  This study tests whether starting rhythm control early in people with atrial fibrillation and tricuspid regurgitation can improve outcomes compared with usual care.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07607093

• Topaz TTVR vs EVOQUE TTVR for severe tricuspid regurgitation

  A study tests whether the TRiCares Topaz transcatheter tricuspid valve replacement system works safely and effectively for adults with severe tricuspid regurgitation who are candidates for valve replacement.

  Recruiting TRiCares · Atlanta, Georgia · NCT07528326

• Robotic transjugular tricuspid valve replacement using the Lux-valve plus system.

  This trial tests a robotic transjugular procedure using the Lux-valve plus to replace the tricuspid valve in adults with severe symptomatic tricuspid regurgitation who are high risk for open surgery.

  Recruiting Prince of Wales Hospital, Shatin, Hong Kong · Shatin · NCT07516145

• LuX-Valve Plus vs EVOQUE for transvenous tricuspid replacement in severe tricuspid regurgitation

  This trial tests whether the LuX-Valve Plus system can safely and effectively treat adults with severe tricuspid regurgitation compared to the EVOQUE device.

  Recruiting at 7 sites Jenscare Innovation Inc. · Naples, Florida and 6 other locations · NCT07454980

• DELINEATE-Prospective: AI-assisted echocardiogram analysis for valve disease

  This project will test whether an AI system can automatically analyze echocardiograms to help doctors detect valve problems in adults who get heart ultrasounds.

  Recruiting Columbia University · New York, New York · NCT07197736

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.