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NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis

NCT03287856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-10

No results posted yet for this study

Summary

The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile

Conditions

  • Transcatheter Aortic Valve Implantation

Interventions

DEVICE

Transcatheter Aortic Valve Implantation (TAVI)

Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

Sponsors & Collaborators

  • NVT GmbH

    lead INDUSTRY

Principal Investigators

  • Ulrich Schaefer, MD · Universitäres Herzzentrum Hamburg, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2018-09-27
Completion
2019-10-27

Countries

  • Germany

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 NCT03287856 on ClinicalTrials.gov