Last reviewed · How we verify
NCT06581471: TRICURE EU
The TRICURE EU Pivotal Study
NA trial testing Transcatheter Tricuspid Valve Replacement in Tricuspid Valve Regurgitation in 80 participants. Currently enrolling.
30 October 2026
Quick facts
| Lead sponsor | TRiCares |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 29 August 2024 |
| Primary completion | 30 October 2026 |
| Estimated completion | 30 December 2030 |
| Sites | 8 locations across Belgium, Germany |
Drugs / interventions tested
- Transcatheter Tricuspid Valve Replacement
Conditions studied
- Tricuspid Valve Regurgitation — all drugs for Tricuspid Valve Regurgitation →
- Heart Valve Disease — all drugs for Heart Valve Disease →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Sponsor
TRiCares
Who can join
18 and older, any sex, with Tricuspid Valve Regurgitation or Heart Valve Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Tricuspid valve edge to edge repair vs replacement - a comparative analysis and future directions.
Hajj J, Kassab J, Zalaquett Z, Harb SC, et al · · 2026 · PMID 40779241 · DOI 10.1080/14796678.2025.2545133
Verify or expand the search:
- PubMed search for NCT06581471
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Transcatheter Tricuspid Valve Replacement
Trials testing the same drug.
- NCT06611579 — Clinical Study of the inQB8 TTVR System · NA · recruiting
- NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
- NCT04905017 — Trisol System EFS Study · NA · recruiting
- NCT04221490 — 2019-06 TRISCEND Study · NA · active not recruiting
Other recruiting trials for Tricuspid Valve Regurgitation
Currently open trials in the same condition.
- NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
- NCT06611579 — Clinical Study of the inQB8 TTVR System · NA · recruiting
- NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
- NCT07342036 — Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion · recruiting
- NCT05760989 — TRISCEND JAPAN Study · NA · active not recruiting
Other TRiCares trials
Trials by the same sponsor.
- NCT05126030 — The TRICURE First in Human Trial · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06581471 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TRiCares
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06581471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing