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Device

NeoChord DS1000 vs. Surgery for Mitral Valve Regurgitation (ReChord Trial)

N/A
Recruiting
Research Sponsored by NeoChord
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is a candidate for mitral valve repair with cardiopulmonary bypass
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

ReChord Trial Summary

This trial is testing a new device to repair mitral valves without needing cardiopulmonary bypass. The goal is to see if it is safe and effective compared to the standard method.

Who is the study for?
This trial is for adults with moderate to severe degenerative mitral valve regurgitation who are suitable for standard surgical repair. Candidates should have specific conditions of the heart's mitral valve, like anterior leaflet prolapse, and must not have had prior mitral surgery or other cardiac procedures within the last 3 months.Check my eligibility
What is being tested?
The study compares a new device called NeoChord DS1000, which repairs the heart's mitral valve without needing to stop the heart and use a bypass machine, against traditional open-heart surgery that does require stopping the heart and using bypass.See study design
What are the potential side effects?
Potential side effects may include complications related to heart surgery such as infection, bleeding, irregular heartbeat patterns, or issues from using cardiopulmonary bypass in traditional repair.

ReChord Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for heart valve surgery with a heart-lung machine.
Select...
I have a specific type of heart valve issue with a single abnormal blood flow detected.
Select...
I am a candidate for heart valve repair surgery with a heart-lung machine.
Select...
My body is suitable for the treatment based on its structure.
Select...
My heart valve leak is moderate to severe.
Select...
I have severe leakage in my heart's mitral valve.
Select...
My heart valve condition involves specific segments with a unique leakage pattern.

ReChord Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.

ReChord Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
Group II: Control GroupActive Control1 Intervention
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair

Find a Location

Who is running the clinical trial?

NeoChordLead Sponsor
4 Previous Clinical Trials
686 Total Patients Enrolled

Media Library

NeoChord DS1000 System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02803957 — N/A
Mitral Valve Regurgitation Research Study Groups: Treatment Group, Control Group
Mitral Valve Regurgitation Clinical Trial 2023: NeoChord DS1000 System Highlights & Side Effects. Trial Name: NCT02803957 — N/A
NeoChord DS1000 System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02803957 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining the research experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively seeking participants with an initial posting date of 11/3/2016 and a most recent update occurring 12/4/2019. The study has to recruit 585 patients from 15 different medical centres."

Answered by AI

How many sites are hosting this clinical research?

"Patients can enroll in this medical trial at Sutter Health/Alta Bates Summitt Medical Center located in Oakland, Piedmont Heart Institute situated in Atlanta, and MedStar Washington Hospital Centre based in Washington DC. There are 12 other enrolment points throughout the US as well."

Answered by AI

Is this research recruiting new participants at the present moment?

"Several sources, including clinicaltrials.gov, confirm that recruitment for this trial is ongoing; the initial posting was on November 3rd 2016 and the study has been updated as recently as December 4th 2019."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
~70 spots leftby Mar 2025