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NeoChord TACT Post-Market Surveillance Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01784055
First received: January 31, 2013
Last updated: August 28, 2016
Last verified: August 2016

January 31, 2013
August 28, 2016
March 2013
July 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01784055 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
NeoChord TACT Post-Market Surveillance Registry
Post-Market Surveillance Registry for the NeoChord DS1000
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample
Patients with Grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement
  • Mitral Valve Insufficiency
  • Heart Valve Diseases
  • Heart Diseases
  • Cardiovascular Diseases
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Lithuania,   Switzerland
 
NCT01784055
800001-001
No
Not Provided
Not Provided
NeoChord
NeoChord
Not Provided
Study Chair: Joerg Seeberger, MD Leipzig University
NeoChord
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP