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Mitroflow DL Post Approval Study- North America

NCT02351726 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-02-20

No results posted yet for this study

Summary

Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.

Conditions

  • Aortic Stenosis
  • Aortic Regurgitation
  • Aortic Valve Insufficiency
  • Heart Valve Diseases
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Congenital Abnormalities
  • Heart Diseases
  • Pathological Conditions, Anatomical

Interventions

DEVICE

Mitroflow DL

Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • John Kern, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02351726 on ClinicalTrials.gov