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

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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 |
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

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
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 |
Study Chair: | Joerg Seeberger, MD | Leipzig University |
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 |