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Safety and Performance Study of the NeoChord Device

NCT01777815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-09-25

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

NeoChord DS1000 Artificial Chordae Delivery System

Sponsors & Collaborators

  • NeoChord

    lead INDUSTRY

Principal Investigators

  • Anno Diegeler, MD · Herz und Gefäß-Klinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-10-31
Completion
2014-08-31

Countries

  • Denmark
  • Germany
  • Italy
  • Lithuania

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 NCT01777815 on ClinicalTrials.gov