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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
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
Is a candidate for mitral valve repair with cardiopulmonary bypass
Must not have
Requires concomitant cardiac procedures
Has undergone prior mitral valve surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific type of heart valve issue with a single abnormal blood flow detected.
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I am a candidate for heart valve repair surgery with a heart-lung machine.
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My heart valve leak is moderate to severe.
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My heart valve condition involves specific segments with a unique leakage pattern.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need additional heart-related procedures.
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I have had surgery on my mitral valve before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~65 spots leftby Nov 2025
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