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European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

Primary Purpose

Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
Sponsored by
NeoChord
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring NeoChord, Mitral Valve Regurgitation, Mitral Valve Prolapse, Artificial Chordae, Mitral Valve Repair

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject age is 18 to 85 years at time of enrollment.
  2. Symptomatic MR (≥3+) confirmed by the echo core lab.
  3. Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non- commissural, confirmed by the echo core lab.
  4. Leaflet-to-Annulus Index (LAI) ≥ 1.25 based on 2D TEE, confirmed by the echo core lab. (1)
  5. Cardiac Index > 2.0.
  6. Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE).
  7. New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa.
  8. Subject deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one cardiac surgeon, one interventional cardiologist, and a cardiac imaging expert).
  9. Transseptal catheterization is deemed feasible by the Subject Screening Committee.
  10. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions including returning for all follow-up visits and has provided written informed consent.

Exclusion Criteria:

  1. MR etiology that is exclusively Secondary (functional).
  2. Echocardiographic evidence of EROA ≤ 0.3cm2.
  3. Valvular leaflet anatomy or pathology deemed not suitable for the NeoChord Implant.
  4. Untreated clinically significant coronary artery disease requiring revascularization.
  5. Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than cardiomyopathy of either ischemic or non-ischemic etiology.
  6. Hypotension (systolic pressure < 90 mmHg)/Cardiogenic shock or other hemodynamic instability requiring theneed for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
  7. Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure.
  8. Evidence of right-sided heart failure with echocardiographic evidence of severe right ventricular dysfunction.
  9. Surgical or interventional procedure planned within 30 days prior to index procedure.
  10. Prior orthotropic heart transplantation.
  11. Life Expectancy < 1 year due to non-cardiac conditions.
  12. Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2.
  13. Any prior mitral valve surgery or transcatheter mitral valve procedure.
  14. Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure.
  15. ModifiedRankinScale>4disability.
  16. Class I indication for biventricular pacing (in patient with CRT device not implanted).
  17. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure.
  18. Need for cardiovascular surgery (other than MV disease).
  19. Aortic or pulmonic valve disease requiring surgery.
  20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  21. Activeendocarditis.
  22. Knownseveresymptomaticcarotidstenosis(>70%via ultrasound).
  23. Active infections requiring current antibiotic therapy.
  24. Active cancer with expected survival < 1 year.
  25. Pregnant or planning pregnancy within next 12 months.
  26. Currently participating in an investigational drug or another device study.
  27. Femoral vein cannot accommodate a 28F catheter or there is evidence of ipsilateral deep vein thrombosis(DVT)).
  28. Hepatic insufficiency (MELD > 10).
  29. Chronic anemia (Hgb < 9).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment with NeoChord Transcatheter Mitral Repair System

    Arm Description

    Implanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair System

    Outcomes

    Primary Outcome Measures

    The ability of the NeoChord device to be placed without Major Device Related Adverse Events.
    Death (Cardiovascular mortality vs non-cardiovascular); Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; Disabling stroke; Myocardial infarction (MVARC definition); Major access site and vascular complications; Fatal or life-threatening bleeding (MVARC Type III-V); Arrhythmia and conduction disorder requiring permanent pacing; Renal Failure requiring dialysis; Cardiac tamponade. All other SAE's and device/procedure-related AE's will be summarized throughout the follow-up duration, as descriptive endpoint data.
    NeoChord Technical Success
    Successful access, delivery, and retrieval of the delivery system; and Successful deployment and correct positioning of the implant; and Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality or stroke, at 30-day follow up.

    Secondary Outcome Measures

    Secondary performance endpoints (MR severity)
    • Change in LV End diastolic volume index (LVEDVI)
    Secondary performance endpoints (MR severity)
    • Change in LV end-systolic volume index (LVESVI)
    Secondary performance endpoints (Patient Success)
    • Changes in New York Heart Association functional Class (NYHA)
    Secondary performance endpoints (Patient Success)
    • 6-minute walk test distance (6MWT)
    Secondary performance endpoints (Patient Success)
    • Kansas City Cardiomyopathy Questionnaire score (KCCQ)
    Secondary performance endpoints (Patient Success)
    • Device dysfunction (Central MR grade > 1) follow-up

    Full Information

    First Posted
    June 8, 2022
    Last Updated
    June 16, 2022
    Sponsor
    NeoChord
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05425628
    Brief Title
    European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
    Official Title
    European First in Human Study of the NeoChord Transcatheter Mitral Repair System to Assess Safety and Performance in Patients With Symptomatic Mitral Regurgitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NeoChord

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
    Detailed Description
    The objective of this First-in-Human (FIH) evaluation is to assess the safety and performance of the NeoChord Transcatheter Mitral Repair System in treating subjects with symptomatic mitral regurgitation, who are at high risk for standard mitral valve surgery, by using a minimally invasive transcatheter mitral valve repair procedure. The NeoChord Transcatheter Mitral Repair System is indicated for use in patients with grade 3+ or 4+ mitral valve regurgitation who are candidates for surgical mitral valve repair or replacement. The intended purpose for the NeoChord Transcatheter Mitral Repair System is for repair of chordal elongation and rupture resulting in mitral valve prolapse.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
    Keywords
    NeoChord, Mitral Valve Regurgitation, Mitral Valve Prolapse, Artificial Chordae, Mitral Valve Repair

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective, multi-center, unblinded, single arm first in human/feasibility clinical study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment with NeoChord Transcatheter Mitral Repair System
    Arm Type
    Experimental
    Arm Description
    Implanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair System
    Intervention Type
    Device
    Intervention Name(s)
    NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
    Intervention Description
    The NeoChord Transcatheter Mitral Repair System is a system of delivery devices and implantable Neochordae and Anchor. The system is designed to percutaneously deliver and deploy the implantable ePTFE sutures, "Neochordae" as artificial chordae at the mitral valve and connect them to the implantable ventricular anchor, "Anchor", using a catheter based system placed into the left side of the heart through the interatrial septum.
    Primary Outcome Measure Information:
    Title
    The ability of the NeoChord device to be placed without Major Device Related Adverse Events.
    Description
    Death (Cardiovascular mortality vs non-cardiovascular); Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; Disabling stroke; Myocardial infarction (MVARC definition); Major access site and vascular complications; Fatal or life-threatening bleeding (MVARC Type III-V); Arrhythmia and conduction disorder requiring permanent pacing; Renal Failure requiring dialysis; Cardiac tamponade. All other SAE's and device/procedure-related AE's will be summarized throughout the follow-up duration, as descriptive endpoint data.
    Time Frame
    30 days
    Title
    NeoChord Technical Success
    Description
    Successful access, delivery, and retrieval of the delivery system; and Successful deployment and correct positioning of the implant; and Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality or stroke, at 30-day follow up.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Secondary performance endpoints (MR severity)
    Description
    • Change in LV End diastolic volume index (LVEDVI)
    Time Frame
    30 days, 90 days, and 180 days post-index procedure
    Title
    Secondary performance endpoints (MR severity)
    Description
    • Change in LV end-systolic volume index (LVESVI)
    Time Frame
    30 days, 90 days, and 180 days post-index procedure
    Title
    Secondary performance endpoints (Patient Success)
    Description
    • Changes in New York Heart Association functional Class (NYHA)
    Time Frame
    30 days, 90 days, and 180 days post-index procedure
    Title
    Secondary performance endpoints (Patient Success)
    Description
    • 6-minute walk test distance (6MWT)
    Time Frame
    30 days, 90 days, and 180 days post-index procedure
    Title
    Secondary performance endpoints (Patient Success)
    Description
    • Kansas City Cardiomyopathy Questionnaire score (KCCQ)
    Time Frame
    30 days, 90 days, and 180 days post-index procedure
    Title
    Secondary performance endpoints (Patient Success)
    Description
    • Device dysfunction (Central MR grade > 1) follow-up
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject age is 18 to 85 years at time of enrollment. Symptomatic MR (≥3+) confirmed by the echo core lab. Primary segmental prolapse or flail of P2 segment only, or P2 segmental prolapse or flail extending to one adjacent segment (P1 or P3), and the primary regurgitant jet is non- commissural, confirmed by the echo core lab. Leaflet-to-Annulus Index (LAI) ≥ 1.25 based on 2D TEE, confirmed by the echo core lab. (1) Cardiac Index > 2.0. Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE). New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa. Subject deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one cardiac surgeon, one interventional cardiologist, and a cardiac imaging expert). Transseptal catheterization is deemed feasible by the Subject Screening Committee. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions including returning for all follow-up visits and has provided written informed consent. Exclusion Criteria: MR etiology that is exclusively Secondary (functional). Echocardiographic evidence of EROA ≤ 0.3cm2. Valvular leaflet anatomy or pathology deemed not suitable for the NeoChord Implant. Untreated clinically significant coronary artery disease requiring revascularization. Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than cardiomyopathy of either ischemic or non-ischemic etiology. Hypotension (systolic pressure < 90 mmHg)/Cardiogenic shock or other hemodynamic instability requiring theneed for inotropic support or intra-aortic balloon pump or other hemodynamic support device. Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure. Evidence of right-sided heart failure with echocardiographic evidence of severe right ventricular dysfunction. Surgical or interventional procedure planned within 30 days prior to index procedure. Prior orthotropic heart transplantation. Life Expectancy < 1 year due to non-cardiac conditions. Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2. Any prior mitral valve surgery or transcatheter mitral valve procedure. Stroke, transient ischemic event, or myocardial infarction within 30 Days prior to index procedure. ModifiedRankinScale>4disability. Class I indication for biventricular pacing (in patient with CRT device not implanted). Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure. Need for cardiovascular surgery (other than MV disease). Aortic or pulmonic valve disease requiring surgery. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Activeendocarditis. Knownseveresymptomaticcarotidstenosis(>70%via ultrasound). Active infections requiring current antibiotic therapy. Active cancer with expected survival < 1 year. Pregnant or planning pregnancy within next 12 months. Currently participating in an investigational drug or another device study. Femoral vein cannot accommodate a 28F catheter or there is evidence of ipsilateral deep vein thrombosis(DVT)). Hepatic insufficiency (MELD > 10). Chronic anemia (Hgb < 9).

    12. IPD Sharing Statement

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    European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation

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