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Safety and Performance Study of the NeoChord Device (TACT)

Primary Purpose

Mitral Valve Regurgitation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NeoChord DS1000 Artificial Chordae Delivery System
Sponsored by
NeoChord
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >= 18 and < 80 years
  • Candidate for surgical mitral valve repair or replacement
  • Isolated posterior leaflet prolapse
  • Moderate to severe or severe mitral valve regurgitation that is degenerative in nature

Exclusion Criteria:

  • Anterior or bi-leaflet prolapse
  • Functional or ischemic MR
  • NYHA Class IV
  • Complex mechanism of MR (leaflet perforation, etc)
  • Significant tethering of leaflets toward LV apex
  • Severely calcified mitral valve annulus
  • Inflammatory valve disease
  • Severe LV dilation

Sites / Locations

  • Aarhus University Hospital, Skejby
  • Kerckhoff-Klinik
  • Herz und Gefäß-Klinik
  • Herzzentrum Leipzig
  • Klinik für Herz-und Gefäßchirurgie
  • San Raffaele
  • Ospedale San Giovanni Battista "Molinette"
  • Vilniaus Universiteto ligonines Santariskiu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanting ePTFE sutures

Arm Description

Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System

Outcomes

Primary Outcome Measures

Procedural Success
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days

Secondary Outcome Measures

Procedural Safety
the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.

Full Information

First Posted
January 25, 2013
Last Updated
September 23, 2014
Sponsor
NeoChord
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1. Study Identification

Unique Protocol Identification Number
NCT01777815
Brief Title
Safety and Performance Study of the NeoChord Device
Acronym
TACT
Official Title
Safety and Performance Study of the NeoChord Suturing Device in Subjects With Degenerative Mitral Valve Disease; Diagnosed With Severe Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoChord

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implanting ePTFE sutures
Arm Type
Experimental
Arm Description
Implanting ePTFE sutures as artificial neochordae using the NeoChord DS1000 Artificial Chordae Delivery System
Intervention Type
Device
Intervention Name(s)
NeoChord DS1000 Artificial Chordae Delivery System
Primary Outcome Measure Information:
Title
Procedural Success
Description
The placement of at least one neochord using the DS1000 System AND a reduction in mitral regurgitation <= 2+ at the time of the procedure AND maintained MR reduction of <= 2+ at 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural Safety
Description
the rate of Major Adverse Events (MAE) defined as a combined endpoint of: death, MI, reoperation for failed surgical repair, non-elective cardiovascular surgery to treat an adverse event, procedural ventilation > 48 hours, procedure-related transfusion of > 2 units blood product, stroke, renal failure, deep wound infection, new onset of permanent AF, and septicemia, through 30 days.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 and < 80 years Candidate for surgical mitral valve repair or replacement Isolated posterior leaflet prolapse Moderate to severe or severe mitral valve regurgitation that is degenerative in nature Exclusion Criteria: Anterior or bi-leaflet prolapse Functional or ischemic MR NYHA Class IV Complex mechanism of MR (leaflet perforation, etc) Significant tethering of leaflets toward LV apex Severely calcified mitral valve annulus Inflammatory valve disease Severe LV dilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anno Diegeler, MD
Organizational Affiliation
Herz und Gefäß-Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
Country
Germany
Facility Name
Herz und Gefäß-Klinik
City
Bad Neustadt
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinik für Herz-und Gefäßchirurgie
City
Munich
Country
Germany
Facility Name
San Raffaele
City
Milan
Country
Italy
Facility Name
Ospedale San Giovanni Battista "Molinette"
City
Torino
Country
Italy
Facility Name
Vilniaus Universiteto ligonines Santariskiu
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
24076529
Citation
Seeburger J, Rinaldi M, Nielsen SL, Salizzoni S, Lange R, Schoenburg M, Alfieri O, Borger MA, Mohr FW, Aidietis A. Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept. J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.
Results Reference
derived

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Safety and Performance Study of the NeoChord Device

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