Safety and Performance Study of the NeoChord Device (TACT)
This study is ongoing, but not recruiting participants.
Sponsor:
NeoChord
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01777815
First received: January 25, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mitral Valve Regurgitation |
Device: NeoChord DS1000 Artificial Chordae Delivery System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation |
Further study details as provided by NeoChord:
Primary Outcome Measures:
- Procedural Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Procedural Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 30 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2014 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Implanting ePTFE sutures
Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
|
Device: NeoChord DS1000 Artificial Chordae Delivery System |
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777815
Locations
| Denmark | |
| Aarhus University Hospital, Skejby | |
| Aarhus, Denmark, 8200 | |
| Germany | |
| Kerckhoff-Klinik | |
| Bad Nauheim, Germany | |
| Herz und Gefäß-Klinik | |
| Bad Neustadt, Germany | |
| Herzzentrum Leipzig | |
| Leipzig, Germany | |
| Klinik für Herz-und Gefäßchirurgie | |
| Munich, Germany | |
| Italy | |
| San Raffaele | |
| Milan, Italy | |
| Ospedale San Giovanni Battista "Molinette" | |
| Torino, Italy | |
| Lithuania | |
| Vilniaus Universiteto ligonines Santariskiu | |
| Vilnius, Lithuania | |
Sponsors and Collaborators
NeoChord
Investigators
| Principal Investigator: | Anno Diegeler, MD | Herz und Gefäß-Klinik |
More Information
No publications provided
| Responsible Party: | NeoChord |
| ClinicalTrials.gov Identifier: | NCT01777815 History of Changes |
| Other Study ID Numbers: | PR-610404-100, 09/1819 |
| Study First Received: | January 25, 2013 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Germany: Ethics Commission Italy: Ministry of Health Denmark: Danish Medicines Agency Lithuania: State Medicine Control Agency - Ministry of Health |
Keywords provided by NeoChord:
|
NeoChord DS1000 Mitral Valve Mitral Valve Regurgitation |
MR Mitral Valve Repair Mitral Valve Prolapse Artificial Chordae |
Additional relevant MeSH terms:
|
Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013