Safety and Performance Study of the NeoChord Device
TACT
2 other identifiers
interventional
30
4 countries
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 25, 2013
CompletedFirst Posted
Study publicly available on registry
January 29, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
3 years
January 25, 2013
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedural Success
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
30 days
Secondary Outcomes (1)
Procedural Safety
30 days
Study Arms (1)
Implanting ePTFE sutures
EXPERIMENTALImplanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeoChordlead
Study Sites (8)
Aarhus University Hospital, Skejby
Aarhus, 8200, Denmark
Kerckhoff-Klinik
Bad Nauheim, Germany
Herz und Gefäß-Klinik
Bad Neustadt an der Saale, Germany
Herzzentrum Leipzig
Leipzig, Germany
Klinik für Herz-und Gefäßchirurgie
Munich, Germany
San Raffaele
Milan, Italy
Ospedale San Giovanni Battista "Molinette"
Torino, Italy
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania
Related Publications (1)
Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.
PMID: 24076529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anno Diegeler, MD
Herz und Gefäß-Klinik
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2013
First Posted
January 29, 2013
Study Start
October 1, 2009
Primary Completion
October 1, 2012
Study Completion
August 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09