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NeoChord TACT Post-Market Surveillance Registry

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ClinicalTrials.gov Identifier: NCT01784055
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
NeoChord

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
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
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01784055


Locations
France
Bordeaux Heart University Hospital (CHU)
Bordeaux, France
Germany
Herzzentrum Dresden
Dresden, Germany
Asklepios Hospital St. Georg
Hamburg, Germany
University Medical Center Hamburg
Hamburg, Germany
Italy
University of Padova Medical School
Padova, Italy, 35127
Lithuania
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania
Switzerland
Universitätsspital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
NeoChord
Investigators
Study Chair: Joerg Seeberger, MD Leipzig University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: NeoChord
ClinicalTrials.gov 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:
NeoChord
DS1000
Mitral Valve
Mitral Valve Regurgitation
 MR
Mitral Valve Repair
Mitral Valve Prolapse
Artificial Chordae

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency