Safety and Performance Study of the NeoChord Device

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: NeoChord DS1000 Artificial Chordae Delivery System

• Registration Number: NCT01777815
• Lead Sponsor: NeoChord

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2012-10
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implanting ePTFE sutures	NeoChord DS1000 Artificial Chordae Delivery System	Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Vilniaus Universiteto ligonines Santariskiu; 🇱🇹 Vilnius, Lithuania

San Raffaele; 🇮🇹 Milan, Italy

Herz und Gefäß-Klinik; 🇩🇪 Bad Neustadt, Germany

Ospedale San Giovanni Battista "Molinette"; 🇮🇹 Torino, Italy

Klinik für Herz-und Gefäßchirurgie; 🇩🇪 Munich, Germany