Clinical trial NCT05425628: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: NeoChord
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, unblinded, single arm first in human/feasibility clinical study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The ability of the NeoChord device to be placed without Major Device Related Adverse Events.
timeFrame: 30 days
measure: NeoChord Technical Success
timeFrame: 30 days
Secondary outcomes:
measure: Secondary performance endpoints (MR severity)
timeFrame: 30 days, 90 days, and 180 days post-index procedure
measure: Secondary performance endpoints (MR severity)
timeFrame: 30 days, 90 days, and 180 days post-index procedure
measure: Secondary performance endpoints (Patient Success)
timeFrame: 30 days, 90 days, and 180 days post-index procedure
measure: Secondary performance endpoints (Patient Success)
timeFrame: 30 days, 90 days, and 180 days post-index procedure
measure: Secondary performance endpoints (Patient Success)
timeFrame: 30 days, 90 days, and 180 days post-index procedure
measure: Secondary performance endpoints (Patient Success)
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: