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PILot Aortic Triflo Valve Study

NCT06119607 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-15

No results posted yet for this study

Summary

A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

TRIFLO Heart Valve

Surgical Aortic Valve Replacement - Mechanical Valve

Sponsors & Collaborators

  • Veranex

    collaborator UNKNOWN

  • Novostia SA

    lead INDUSTRY

Principal Investigators

  • Kęstutis Ručinskas, Prof. · Vilnius University Hospital Santaros Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-12-31
Completion
2029-06-30

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119607 on ClinicalTrials.gov