NeoChord TACT Post-Market Surveillance Registry

August 31, 2017 updated by: NeoChord

Post-Market Surveillance Registry for the NeoChord DS1000

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Bordeaux Heart University Hospital (CHU)
  • Germany
      • Dresden, Germany
        • Herzzentrum Dresden
      • Hamburg, Germany
        • University Medical Center Hamburg
      • Hamburg, Germany
        • Asklepios Hospital St. Georg
  • Italy
      • Padova, Italy, 35127
        • University of Padova Medical School
  • Lithuania
      • Vilnius, Lithuania
        • Vilniaus Universiteto ligonines Santariskiu
  • Switzerland
      • Basel, Switzerland, CH-4031
        • Universitatsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement

Description

Inclusion Criteria:

  • Grade 3+ or 4+ mitral valve regurgitation

Exclusion Criteria:

  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • Active bacterial endocarditis
  • Complex mechanism of MR (leaflet perforation, etc.)
  • Significant tethering of leaflets
  • Inflammatory valve disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoChord

Investigators

  • Study Chair: Joerg Seeberger, MD, Leipzig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 800001-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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