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CardioCel Tri-leaflet Repair Study

NCT02629328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-01-29

No results posted yet for this study

Summary

This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.

Conditions

  • Aortic Stenosis
  • Aortic Insufficiency

Interventions

DEVICE

CardioCel

Treatment with CardioCel implant

Sponsors & Collaborators

  • Anteris Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Dominico Mazzitelli, M.D. · German Heart Centre of the Technical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-07-05
Completion
2018-11-19

Countries

  • Belgium

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 NCT02629328 on ClinicalTrials.gov