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

June 16, 2022 updated by: NeoChord

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment with NeoChord Transcatheter Mitral Repair System
Implanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair System
Device: NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The ability of the NeoChord device to be placed without Major Device Related Adverse Events.
Time Frame: 30 days
  • 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.
30 days
NeoChord Technical Success
Time Frame: 30 days
  • 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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary performance endpoints (MR severity)
Time Frame: 30 days, 90 days, and 180 days post-index procedure
• Change in LV End diastolic volume index (LVEDVI)
30 days, 90 days, and 180 days post-index procedure
Secondary performance endpoints (MR severity)
Time Frame: 30 days, 90 days, and 180 days post-index procedure
• Change in LV end-systolic volume index (LVESVI)
30 days, 90 days, and 180 days post-index procedure
Secondary performance endpoints (Patient Success)
Time Frame: 30 days, 90 days, and 180 days post-index procedure
• Changes in New York Heart Association functional Class (NYHA)
30 days, 90 days, and 180 days post-index procedure
Secondary performance endpoints (Patient Success)
Time Frame: 30 days, 90 days, and 180 days post-index procedure
• 6-minute walk test distance (6MWT)
30 days, 90 days, and 180 days post-index procedure
Secondary performance endpoints (Patient Success)
Time Frame: 30 days, 90 days, and 180 days post-index procedure
• Kansas City Cardiomyopathy Questionnaire score (KCCQ)
30 days, 90 days, and 180 days post-index procedure
Secondary performance endpoints (Patient Success)
Time Frame: 30 days
• Device dysfunction (Central MR grade > 1) follow-up
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NeoChord

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR-610710-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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