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TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

TVMR With the Innovalve System Trial - Pilot Study in Belgium

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05263375
Enrollment
0
Registered
2022-03-02
Start date
2023-06-01
Completion date
2025-06-01
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Brief summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Interventions

DEVICEInnovalve TMVR system

Innovalve TMVR system

Sponsors

Innovalve Bio Medical Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinically significant, symptomatic mitral regurgitation * High risk for open-heart surgery * Meets anatomical criteria

Exclusion criteria

* Unsuitable anatomy * Patient is inoperable * EF \<30%

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with implant or delivery related serious adverse events at 30 days30 daysNumber of patients with implant or delivery related serious adverse events at 30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026