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NCT01784055 Clinical Trial

NeoChord TACT Post-Market Surveillance Registry

Cardiovascular Diseases Clinical Trial

Official title:
Post-Market Surveillance Registry for the NeoChord DS1000

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01784055
Other study ID # 800001-001
Secondary ID
Status Completed
Phase
First received January 31, 2013
Last updated August 31, 2017
Start date March 2013
Est. completion date July 2016

Study information
Verified date August 2017
Source NeoChord
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Bordeaux Heart University Hospital (CHU) Bordeaux
Germany Herzzentrum Dresden Dresden
Germany Asklepios Hospital St. Georg Hamburg
Germany University Medical Center Hamburg Hamburg
Italy University of Padova Medical School Padova
Lithuania Vilniaus Universiteto ligonines Santariskiu Vilnius
Switzerland Universitätsspital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
NeoChord

Countries where clinical trial is conducted

France,  Germany,  Italy,  Lithuania,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedure Success 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 The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
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