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Mitral Valve InsufficiencyNCT05425628

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

A study testing NeoChord Transcatheter Mitral Repair System (or "NeoChord System") in people with Mitral Valve Insufficiency and Mitral Valve Prolapse, run by NeoChord.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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).

About this study

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

Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.

Read the 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.

Being tested
NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
Keywords
NeoChord, Mitral Valve Regurgitation, Mitral Valve Prolapse, Artificial Chordae, Mitral Valve Repair
Medical subject headings
Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeoChord Transcatheter Mitral Repair System (or "NeoChord System")Device

    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.

Study groups in NCT05425628
Study groupRoleWhat they receive
Treatment with NeoChord Transcatheter Mitral Repair SystemExperimentalImplanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair System
Receives: Device: NeoChord Transcatheter Mitral Repair System (or "NeoChord System")

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

  2. 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.

    Measured: 30 days

Secondary outcomes (6)

  1. Secondary performance endpoints (MR severity)

    • Change in LV End diastolic volume index (LVEDVI)

    Measured: 30 days, 90 days, and 180 days post-index procedure

  2. Secondary performance endpoints (MR severity)

    • Change in LV end-systolic volume index (LVESVI)

    Measured: 30 days, 90 days, and 180 days post-index procedure

  3. Secondary performance endpoints (Patient Success)

    • Changes in New York Heart Association functional Class (NYHA)

    Measured: 30 days, 90 days, and 180 days post-index procedure

  4. Secondary performance endpoints (Patient Success)

    • 6-minute walk test distance (6MWT)

    Measured: 30 days, 90 days, and 180 days post-index procedure

  5. Secondary performance endpoints (Patient Success)

    • Kansas City Cardiomyopathy Questionnaire score (KCCQ)

    Measured: 30 days, 90 days, and 180 days post-index procedure

  6. Secondary performance endpoints (Patient Success)

    • Device dysfunction (Central MR grade > 1) follow-up

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Prospective, multi-center, unblinded, single arm first in human/feasibility clinical study.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425628
Sponsor's protocol ID
PR-610710-001
Status last verified
Jun 2022
First submitted
8 Jun 2022
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NeoChord Transcatheter Mitral Repair System (or "NeoChord System") in people with Mitral Valve Insufficiency and Mitral Valve Prolapse, run by NeoChord.

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 10 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

The ability of the NeoChord device to be placed without Major Device Related Adverse Events. (time frame: 30 days). 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?

On the ClinicalTrials.gov record for NCT05425628.

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 21 Jun 2022.

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