Safety and Performance Study of the NeoChord Device (TACT)

N

NeoChord

Status

Completed

Conditions

Mitral Valve Regurgitation

Treatments

Device: NeoChord DS1000 Artificial Chordae Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01777815
09/1819 (Other Identifier)
PR-610404-100

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Implanting ePTFE sutures
Experimental group
Description:
Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
Treatment:
Device: NeoChord DS1000 Artificial Chordae Delivery System

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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