- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425628
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
30
Phase
- 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
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
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 |
Intervention / Treatment |
---|---|
Experimental: Treatment with NeoChord Transcatheter Mitral Repair System
Implanting ePTFE sutures as artificial neochordae using NeoChord Transcatheter Mitral Repair 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
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
|
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
|
Without any procedural mortality or stroke, at 30-day follow up. |
30 days
|
Secondary Outcome Measures
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
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)
August 1, 2022
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
June 8, 2022
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
June 21, 2022
Last Update Submitted That Met QC Criteria
June 16, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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Clinical Trials on NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
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NeoChordRecruitingMitral Valve InsufficiencyUnited States
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NeoChordRecruitingHeart Valve Diseases | Mitral Regurgitation | Mitral Valve Insufficiency | Mitral Valve Prolapse | Mitral Valve DiseaseGermany, Greece, Switzerland
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NeoChordCompletedMitral Valve RegurgitationDenmark, Germany, Italy, Lithuania
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Hangzhou Valgen Medtech Co., LtdEnrolling by invitationDegenerative Mitral Valve DiseaseChina
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Hangzhou Valgen Medtech Co., LtdRecruitingMitral Regurgitation FunctionalChina
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Shanghai Shenqi Medical Technology Co., LtdActive, not recruitingFunctional Mitral RegurgitationChina
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Polares Medical SAPolares Medical, Inc.Not yet recruiting
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Edwards LifesciencesRecruitingMitral Regurgitation | Mitral Insufficiency | Functional Mitral Regurgitation | Degenerative Mitral Valve DiseaseUnited States, Canada, Switzerland, Germany
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Polares Medical SAPolares Medical, Inc.Not yet recruitingFunctional Mitral Regurgitation