MedTrace Logo

Clinical Investigation for the Foldax Tria Aortic Heart Valve- India

NCT06192706 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-05

No results posted yet for this study

Summary

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Insufficiency
  • Aortic Valve Calcification
  • Aortic Valve Disease

Interventions

DEVICE

Foldax Tria Aortic Valve

Aortic Valve Replacement

Sponsors & Collaborators

  • Foldax, Inc

    lead INDUSTRY

Principal Investigators

  • Kaushal Pandey, MBBS, MS · Hinduja Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-07-01
Completion
2024-09-01

Countries

  • India

Study Locations

More Related Trials

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 NCT06192706 on ClinicalTrials.gov