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NeoChord TACT Post-Market Surveillance Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NeoChord
Sponsor:
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01784055
First received: January 31, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System


Condition
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


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01784055

Contacts
Contact: Uwe Kasten, BSc., PA + 49 172 4528 995 ukasten@neochord.com

Locations
France
Bordeaux Heart University Hospital (CHU) Recruiting
Bordeaux, France
Principal Investigator: Louis Labrousse, MD         
Germany
Herzzentrum Dresden Recruiting
Dresden, Germany
Principal Investigator: Klaus Matschke, MD         
Asklepios Hospital St. Georg Recruiting
Hamburg, Germany
Principal Investigator: Michael Schmoeckel, MD         
University Medical Center Hamburg Recruiting
Hamburg, Germany
Principal Investigator: Hendrik Treede, MD         
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Principal Investigator: Jörg Seeburger, MD         
Lithuania
Vilniaus Universiteto ligonines Santariskiu Recruiting
Vilnius, Lithuania
Principal Investigator: Adurius Aidietis, MD         
Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, CH-4031
Principal Investigator: Friedrich Eckstein, MD         
Sponsors and Collaborators
NeoChord
Investigators
Principal Investigator: Jörg Seeburger, MD Herzzentrum Leipzig
  More Information

No publications provided

Responsible Party: NeoChord
ClinicalTrials.gov Identifier: NCT01784055     History of Changes
Other Study ID Numbers: 800001-001
Study First Received: January 31, 2013
Last Updated: September 23, 2014
Health Authority: 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:
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency

ClinicalTrials.gov processed this record on November 25, 2014