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NeoChord TACT Post-Market Surveillance Registry

This study has been completed.
Information provided by (Responsible Party):
NeoChord Identifier:
First received: January 31, 2013
Last updated: August 28, 2016
Last verified: August 2016
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Post-Market Surveillance Registry for the NeoChord DS1000

Resource links provided by NLM:

Further study details as provided by NeoChord:

Primary Outcome Measures:
  • Procedure Success [ Time Frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. ] [ Designated as safety issue: No ]
    To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure

Enrollment: 126
Study Start Date: March 2013
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement

Inclusion Criteria:

  • Grade 3+ or 4+ mitral valve regurgitation

Exclusion Criteria:

  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • Active bacterial endocarditis
  • Complex mechanism of MR (leaflet perforation, etc.)
  • Significant tethering of leaflets
  • Inflammatory valve disease
  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 identifier: NCT01784055

Bordeaux Heart University Hospital (CHU)
Bordeaux, France
Herzzentrum Dresden
Dresden, Germany
Asklepios Hospital St. Georg
Hamburg, Germany
University Medical Center Hamburg
Hamburg, Germany
University of Padova Medical School
Padova, Italy, 35127
Vilniaus Universiteto ligonines Santariskiu
Vilnius, Lithuania
Universitätsspital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
Study Chair: Joerg Seeberger, MD Leipzig University
  More Information

Responsible Party: NeoChord Identifier: NCT01784055     History of Changes
Other Study ID Numbers: 800001-001 
Study First Received: January 31, 2013
Last Updated: August 28, 2016
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency processed this record on October 21, 2016