Status:
UNKNOWN
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Lead Sponsor:
NeoChord
Conditions:
Mitral Valve Insufficiency
Mitral Valve Prolapse
Eligibility:
All Genders
18-85 years
Phase:
NA
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 regurgitat...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05425628
Start Date
August 1 2022
End Date
December 1 2023
Last Update
June 21 2022
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