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NCT04073979
MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study
NA trial testing Mistral implantation in Tricuspid Valve Regurgitation in 9 participants. Completed in 31 December 2022.
31 January 2021
Quick facts
| Lead sponsor | Mitralix |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 2 April 2019 |
| Primary completion | 31 January 2021 |
| Estimated completion | 31 December 2022 |
| Sites | 4 locations across Germany |
Drugs / interventions tested
- Mistral implantation
Conditions studied
- Tricuspid Valve Regurgitation — all drugs for Tricuspid Valve Regurgitation →
Sponsor
Mitralix
Who can join
18 and older, any sex, with Tricuspid Valve Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Transcatheter tricuspid valve interventions: Current status and future perspectives.
Alperi A, Almendárez M, Álvarez R, Moris C, et al · · 2022 · cited 19× · PMID 36187002 · DOI 10.3389/fcvm.2022.994502 -
One-year outcomes of transcatheter tricuspid valve repair with the Mistral device.
Piayda K, Bertog S, Steffan J, Ilioska-Damköhler P, et al · · 2023 · cited 5× · PMID 36912107 · DOI 10.4244/eij-d-22-01032 -
Percutaneous Tricuspid Valve Repair.
Mangieri A, Sticchi A, Gohar A, Regazzoli D, et al · · 2022 · cited 3× · PMID 39076922 · DOI 10.31083/j.rcm2307220
Verify or expand the search:
- PubMed search for NCT04073979
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mistral implantation
Trials testing the same drug.
- NCT04071652 — MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study · NA · completed
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
- NCT06581471 — The TRICURE EU Pivotal Study · NA · recruiting
- NCT07342036 — Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion · recruiting
Other Mitralix trials
Trials by the same sponsor.
- NCT05767645 — Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study · NA · unknown
- NCT04071652 — MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study · NA · completed
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 NCT04073979 (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 Mitralix
- Last refreshed: 19 October 2023
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/NCT04073979.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing