TRIFORMIS RESILIA heart valve real-world results in tricuspid disease

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, multicenter, single-arm study enrolling at least 75 participants across up to 15 sites in the United States. It collects real-world clinical outcomes after implantation of the TRIFORMIS RESILIA heart valve (model 11300T) in native or prosthetic tricuspid valve disease. Patients will be followed through scheduled visits to monitor safety and performance. The study does not include a control group and focuses on post-market experience in routine clinical practice. Enrollment is limited to adults who can provide informed consent and attend follow-up, with nitinol hypersensitivity being an exclusion criterion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older
* Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction
* Provide written informed consent prior to the 30-day imaging follow-up
* Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

• Untreatable hypersensitivity to nitinol alloys (nickel and titanium)

Where it's running

• Ascension St. Vincent's Hospital
  Carmel, Indiana, United States Recruiting

Study contacts

• Study coordinator: Aya Westbrook, PhD
• Email: Aya_Westbrook@edwards.com
• Phone: 949-250-2500

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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.