Safety and Performance Study of the NeoChord Device

Mitral Valve Regurgitation Clinical Trial

— TACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777815
• Other study ID #: PR-610404-100
• Secondary ID: 09/1819
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: September 23, 2014
• Start date: October 2009
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: NeoChord
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionItaly: Ministry of HealthDenmark: Danish Medicines AgencyLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• NeoChord DS1000 Artificial Chordae Delivery System

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Herz und Gefäß-Klinik	Bad Neustadt
Germany	Herzzentrum Leipzig	Leipzig
Germany	Klinik für Herz-und Gefäßchirurgie	Munich
Italy	San Raffaele	Milan
Italy	Ospedale San Giovanni Battista "Molinette"	Torino
Lithuania	Vilniaus Universiteto ligonines Santariskiu	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
NeoChord

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Procedural Safety	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.	30 days	Yes