Safety and Performance Study of the NeoChord Device (TACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01777815
First received: January 25, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Mitral Valve Regurgitation
Device: NeoChord DS1000 Artificial Chordae Delivery System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation

Further study details as provided by NeoChord:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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:
  • Procedural Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: October 2009
Study Completion Date: August 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implanting ePTFE sutures
Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
Device: NeoChord DS1000 Artificial Chordae Delivery System

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777815

Locations
Denmark
Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Germany
Kerckhoff-Klinik
Bad Nauheim, Germany
Herz und Gefäß-Klinik
Bad Neustadt, Germany
Herzzentrum Leipzig
Leipzig, Germany
Klinik für Herz-und Gefäßchirurgie
Munich, Germany
Italy
San Raffaele
Milan, Italy
Ospedale San Giovanni Battista "Molinette"
Torino, Italy
Lithuania
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania
Sponsors and Collaborators
NeoChord
Investigators
Principal Investigator: Anno Diegeler, MD Herz und Gefäß-Klinik
  More Information

No publications provided by NeoChord

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NeoChord
ClinicalTrials.gov Identifier: NCT01777815     History of Changes
Other Study ID Numbers: PR-610404-100, 09/1819
Study First Received: January 25, 2013
Last Updated: September 23, 2014
Health Authority: Germany: Ethics Commission
Italy: Ministry of Health
Denmark: Danish Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by NeoChord:
NeoChord
DS1000
Mitral Valve
Mitral Valve Regurgitation
MR
Mitral Valve Repair
Mitral Valve Prolapse
Artificial Chordae

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 21, 2014