Transcatheter echo guided mitral valve repair with NeoChord implementation: Results from NeoChord Independent International Registry
CAUTION: Investigational Device Limited by Federal (United States) Law to Investigational Use.
ClinicalTrials.gov Identifier: NCT0177815
The TACT trial is a multi-center, nonrandomized, prospective evaluation of safety and efficacy of the NeoChord DS1000 System. Total enrollment included thirty subjects across seven European sites. Enrollment commenced in 2009. Study follow-up was complete in August 2014.
Results of the TACT Trial are reported in the following publication:
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.
Additional information regarding the TACT Trial may be found at www.clinicaltrials.gov.
ClinicalTrials.gov Identifier: NCT01784055
The TACT Registry is a post-market survellience study assessing the long-term performance of the NeoChord DS1000 System. Total enrollment in the study included 126 subjects across seven European sites. Enrollment commenced in 2013. Study follow-up was completed in July 2016.
Additional information regarding the TACT Registry may be found at www.clinicaltrials.gov.
US Pivotal Study
IDE Trial for the NeoChord Artificial Chordae Delivery System, Model DS1000.
ClinicalTrials.gov Identifier: NCT02803957
The objective of this study is to assess the safety and effectiveness of the NeoChord DS1000 System in subjects with degenerative mitral valve disease. The study is designed as a randomized control trial comparing use of the study device versus Open Surgical Repair. Enrollment in the trial will include up to 585 subjects at up to twenty U.S. centers.
Additional information regarding the US Pivotal Study may be found at www.clinicaltrials.gov.