Mitral Valve InsufficiencyReChordNCT02803957
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
A study testing NeoChord DS1000 and Surgical Mitral Valve Repair in people with Mitral Valve Insufficiency, run by NeoChord at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- NeoChord DS1000 and Surgical Mitral Valve Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 585 participants
- Where
- 14 sitesUnited States
- Study dates
- 3 Nov 2016to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior mitral valve surgery
- Concomitant cardiac procedures
- Other cardiac procedures within 3 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30339
Johns Hopkins University
Baltimore, Maryland, 21287
Pinnacle Health
Harrisburg, Pennsylvania, 17110
Franciscan Health
Indianapolis, Indiana, 46237
St. Thomas
Nashville, Tennessee, 37205
Mount Sinai, Icahn School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Baylor - Plano
Plano, Texas, 75093
Mercy General Hospital
Sacramento, California, 95819
Stanford University
Stanford, California, 94305
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Valley Health System | Virginia
Winchester, Virginia, 22601
About this study
Official title: Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
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).
- Conditions
- Mitral Valve Insufficiency
- Being tested
- NeoChord DS1000, Surgical Mitral Valve Repair
- Keywords
- Degenerative, Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoChord DS1000Device
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Surgical Mitral Valve RepairDevice
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000 Receives: Device: NeoChord DS1000 |
| Control Group | Active comparator | Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair Receives: Device: Surgical Mitral Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start3 Nov 2016
- Primary completionJan 2021
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 585 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoChord
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803957
- Sponsor's protocol ID
- NeoChord: PR-610405-100
- Acronym
- ReChord
- Status last verified
- Mar 2023
- First submitted
- 9 May 2016
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
- ClinicalTrials.gov ID
- NCT02803957
- Acronym / sponsor ID
- ReChord / NeoChord: PR-610405-100
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Degenerative, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 585 participants (estimated)
- Lead sponsor
- NeoChordIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: NeoChord DS1000Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000 |
| Control Group | Active comparator | Device: Surgical Mitral Valve RepairSubjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Prior mitral valve surgery
- Concomitant cardiac procedures
- Other cardiac procedures within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoChord DS1000Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000 | Device | Treatment Group |
| Surgical Mitral Valve RepairSurgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae. | Device | Control Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoChord DS1000 and Surgical Mitral Valve Repair in people with Mitral Valve Insufficiency, run by NeoChord at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.