TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) (NCT07684313)
Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)
🩺 Plain-English Summary (8th-Grade Level)
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.
Who can join: Review the eligibility criteria below.
Location: Ascension St. Vincent's Hospital — Carmel, Indiana
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Ascension St. Vincent's Hospital — Carmel, Indiana
📞 Contact the Study Coordinator
Phone: (949) 250-2500
Email: Aya_Westbrook@edwards.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Heart Valve Diseases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.