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NeoChord TACT Post-Market Surveillance Registry

This study is currently recruiting participants.
Verified March 2013 by NeoChord
Sponsor:
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01784055
First received: January 31, 2013
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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: 50
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
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) Not yet recruiting
Bordeaux, France
Principal Investigator: Louis Labrousse, MD            
Germany
Herzzentrum Dresden Not yet recruiting
Dresden, Germany
Principal Investigator: Klaus Matschke, MD            
Mediclin Heart Institute Not yet recruiting
Lahr, Germany
Principal Investigator: Juergen Ennker, MD            
Herzzentrum Leipzig Not yet recruiting
Leipzig, Germany
Principal Investigator: Jörg Seeburger, MD            
Klinikum Nuernberg Not yet recruiting
Nuremberg, Germany
Principal Investigator: Theodor Fischlein, MD            
Robert-Bosch-Hospital Not yet recruiting
Stuttgart, Germany
Principal Investigator: Ulrich Franke, MD            
Lithuania
Vilniaus Universiteto ligonines Santariskiu Recruiting
Vilnius, Lithuania
Principal Investigator: Adurius Aidietis, 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: March 27, 2013
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 May 21, 2013