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Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02803957
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
NeoChord

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE November 3, 2016
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group. [ Time Frame: Post-operative Day (POD) 30 ]
  • Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group. [ Time Frame: Post-operative Day (POD) 30 ]
  • Proportion of subjects free of moderate or severe mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Official Title  ICMJE Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Brief Summary The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Insufficiency
Intervention  ICMJE
  • Device: NeoChord DS1000
    Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
  • Device: Surgical Mitral Valve Repair
    Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
Study Arms  ICMJE
  • Experimental: Treatment Group
    Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
    Intervention: Device: NeoChord DS1000
  • Active Comparator: Control Group
    Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
    Intervention: Device: Surgical Mitral Valve Repair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2017)
585
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
510
Estimated Study Completion Date  ICMJE July 2027
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is a candidate for mitral valve repair with cardiopulmonary bypass
  • Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
  • Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
  • Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
  • Anatomic and general suitability

Exclusion Criteria:

  • Prior mitral valve surgery
  • Concomitant cardiac procedures
  • Other cardiac procedures within 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David H Adams, MD 212-659-6820 david.adams@mountsinai.org
Contact: Michael Borger, MD, Ph.D. +49-341-865-1421 Michael.Borger@helios-kliniken.de
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02803957
Other Study ID Numbers  ICMJE NeoChord: PR-610405-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NeoChord
Study Sponsor  ICMJE NeoChord
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NeoChord
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP