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BIOVALVE - I / II Clincial Investigation

NCT02249000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-06-11

No results posted yet for this study

Summary

First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve implantation

Conditions

  • Heart Valve Diseases
  • Aortic Valve Stenosis

Interventions

DEVICE

BIOVALVE prosthesis

Transcatheter Aortic Valve Replacement (TAVR)

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Hendrik Treede, MD · Universitätsklinikum Halle (Saale), Germany

  • Ulrich Schaefer, MD · University Heart Center Hamburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-03-31
Completion
2023-05-31

Countries

  • Belgium
  • Germany
  • Netherlands
  • Switzerland

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 NCT02249000 on ClinicalTrials.gov