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NeoChord TACT Post-Market Surveillance Registry

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01784055

First Posted: February 5, 2013

Last Update Posted: August 30, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

NeoChord

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

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. ]
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	January 31, 2013
First Posted:	February 5, 2013
Last Update Posted:	August 30, 2016
Last Verified:	August 2016

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

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