Last reviewed · How we verify

NCT04073979

MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

Completed NA Last updated 19 October 2023
What this trial tests

NA trial testing Mistral implantation in Tricuspid Valve Regurgitation in 9 participants. Completed in 31 December 2022.

Timeline
2 April 2019
Primary endpoint
31 January 2021
31 December 2022

Quick facts

Lead sponsorMitralix
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date2 April 2019
Primary completion31 January 2021
Estimated completion31 December 2022
Sites4 locations across Germany

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other trials of Mistral implantation

Trials testing the same drug.

Other recruiting trials for Tricuspid Valve Regurgitation

Currently open trials in the same condition.

Other Mitralix trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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