NeoChord TACT Post-Market Surveillance Registry
This study has been completed.
Sponsor:
NeoChord
Information provided by (Responsible Party):
NeoChord
ClinicalTrials.gov Identifier:
NCT01784055
First received: January 31, 2013
Last updated: August 28, 2016
Last verified: August 2016
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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
| 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) |
Eligibility| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784055
Locations
| France | |
| Bordeaux Heart University Hospital (CHU) | |
| Bordeaux, France | |
| Germany | |
| Herzzentrum Dresden | |
| Dresden, Germany | |
| Asklepios Hospital St. Georg | |
| Hamburg, Germany | |
| University Medical Center Hamburg | |
| Hamburg, Germany | |
| Italy | |
| University of Padova Medical School | |
| Padova, Italy, 35127 | |
| Lithuania | |
| Vilniaus Universiteto ligonines Santariskiu | |
| Vilnius, Lithuania | |
| Switzerland | |
| Universitätsspital Basel | |
| Basel, Switzerland, CH-4031 | |
Sponsors and Collaborators
NeoChord
Investigators
| Study Chair: | Joerg Seeberger, MD | Leipzig University |
More Information
| Responsible Party: | NeoChord |
| ClinicalTrials.gov 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:
|
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 September 30, 2016