UnknownNot Applicable

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

30 participantsStarted 2022-08-01

Plain-language summary

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

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.

The ability of the NeoChord device to be placed without Major Device Related Adverse Events.

Timeframe: 30 days

NeoChord Technical Success

Timeframe: 30 days

NCT IDNCT05425628

SponsorNeoChord

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-01

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. 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.