- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777815
Safety and Performance Study of the NeoChord Device (TACT)
September 23, 2014 updated by: NeoChord
Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
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
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Aarhus, Denmark, 8200
- Aarhus University Hospital, Skejby
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Bad Nauheim, Germany
- Kerckhoff-Klinik
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Bad Neustadt, Germany
- Herz und Gefäß-Klinik
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Leipzig, Germany
- Herzzentrum Leipzig
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Munich, Germany
- Klinik für Herz-und Gefäßchirurgie
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Milan, Italy
- San Raffaele
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Torino, Italy
- Ospedale San Giovanni Battista "Molinette"
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Vilnius, Lithuania
- Vilniaus Universiteto ligonines Santariskiu
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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
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >= 18 and < 80 years
- Candidate for surgical mitral valve repair or replacement
- Isolated posterior leaflet prolapse
- Moderate to severe or severe mitral valve regurgitation that is degenerative in nature
Exclusion Criteria:
- Anterior or bi-leaflet prolapse
- Functional or ischemic MR
- NYHA Class IV
- Complex mechanism of MR (leaflet perforation, etc)
- Significant tethering of leaflets toward LV apex
- Severely calcified mitral valve annulus
- Inflammatory valve disease
- Severe LV dilation
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implanting ePTFE sutures
Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Procedural Success
Time Frame: 30 days
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The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural Safety
Time Frame: 30 days
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the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anno Diegeler, MD, Herz und Gefäß-Klinik
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 25, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Estimate)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 23, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-610404-100
- 09/1819 (Other Identifier: FEKI)
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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