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A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

NCT02434263 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2021-10-19

No results posted yet for this study

Summary

The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients. Following initial implantation, all patients will have clinical follow up at 30 days, 3, months, 6 months and 12 months

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Hydra TAVI

Percutaneous Replacement of the Diseased Aortic Valve

Sponsors & Collaborators

  • MedPass International

    collaborator INDUSTRY

  • Vascular Innovations Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-13
Primary Completion
2022-07-31
Completion
2025-07-31

Countries

  • Greece
  • Hong Kong
  • Lithuania
  • New Zealand
  • Poland
  • Thailand

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 NCT02434263 on ClinicalTrials.gov