Safety and Performance Study of the NeoChord Device (TACT)

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)

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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