Safety and Performance Study of the NeoChord Device

Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01777815

Acronym

TACT

Enrollment

Registered

2013-01-29

Start date

2009-10-31

Completion date

2014-08-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

Keywords

NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae

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.

Interventions

DEVICENeoChord DS1000 Artificial Chordae Delivery System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Procedural Success	30 days	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

Measure	Time frame	Description
Procedural Safety	30 days	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.

Countries

Denmark, Germany, Italy, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026