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NeoChord TACT Post-Market Surveillance Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784055
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):

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

Condition or disease
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases

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Study Type : Observational [Patient Registry]
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Post-Market Surveillance Registry for the NeoChord DS1000
Study Start Date : March 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784055

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Bordeaux Heart University Hospital (CHU)
Bordeaux, France
Herzzentrum Dresden
Dresden, Germany
Asklepios Hospital St. Georg
Hamburg, Germany
University Medical Center Hamburg
Hamburg, Germany
University of Padova Medical School
Padova, Italy, 35127
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania
Universitätsspital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
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Study Chair: Joerg Seeberger, MD Leipzig University

Additional Information:

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Responsible Party: NeoChord Identifier: NCT01784055     History of Changes
Other Study ID Numbers: 800001-001
First Posted: February 5, 2013    Key Record Dates
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018
Last Verified: August 2017
Keywords provided by NeoChord:
Mitral Valve
Mitral Valve Regurgitation
Mitral Valve Repair
Mitral Valve Prolapse
Artificial Chordae
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency
Cardiovascular Diseases