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: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (2 items).
Location: Ascension St. Vincent's Hospital — Carmel, Indiana
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Untreatable hypersensitivity to nitinol alloys (nickel and titanium)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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.
More studies in Heart Valve Diseases
- Paired-Ring Mitral Annuloplasty Ring Sizing Device — Glenview, Illinois
- Transpacific TAVR Registry — Stanford, California
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.