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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: NeoChord DS1000 Device: Surgical Mitral Valve Repair Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Actual Study Start Date : November 3, 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
 Device: NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Active Comparator: Control Group
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02803957


Contacts
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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

Locations
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Sponsors and Collaborators
NeoChord
More Information
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Responsible Party: NeoChord
ClinicalTrials.gov Identifier: NCT02803957    
Other Study ID Numbers: NeoChord: PR-610405-100
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NeoChord:
Degenerative
Mitral Regurgitation
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases