Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

Korábbi kezelés

• Mitral valve area \<4.0 cm2 (if new device therapy may further decrease the mitral orifice area)
• Any prior mitral valve surgery or transcatheter mitral valve procedure
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
• Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch System (e.g., femoral arteries will not support an 20F system)
• Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to procedure.
• Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 1 month
• Subjects on high dose steroids or immunosuppressant therapy

Más betegség

• Life expectancy \<1 yr due to noncardiac conditions
• NYHA functional class IVb or ACC/AHA stage D heart failure
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
• Stroke or transient ischemic event within 30 days
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
• Untreated clinically significant coronary artery disease requiring revascularization
• Myocardial infarction ≤ 30 days
• Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE guidelines; core lab assessment)
• Aortic valve disease requiring surgery
• Need for any cardiovascular surgery (other than for MV disease)
• Known allergy to nickel, polyester, or polyethylene
• Active infections requiring current antibiotic therapy
• Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits

Laborértékek

• Renal insufficiency (i.e., eGFR of \<30ml/min/1.73m2; Stage 4 or 5 CKD)

Egyéb

• Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
• Fixed pulmonary artery systolic pressure \>70 mm Hg
• Mitral valve anatomy which may preclude proper device treatment
• Modified Rankin Scale ≥ 4 disability
• Severe symptomatic carotid stenosis (\>70% by ultrasound).
• Moderate or severe aortic valve stenosis or regurgitation
• Aortic valve prosthesis
• Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus, or vegetation
• Active endocarditis
• Subjects in whom transesophageal echocardiography is contraindicated
• Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
• Patient is unable or unwilling to sign written patient information sheet and informed consent form before study enrollment. This study excludes vulnerable populations as defined in protocol section 18.

• Age ≥ 18 years
• Subjects who present with heart failure with or without functional mitral regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology
  • For subjects with FMR, severity of FMR: ≥ Moderate 2+
  • For subjects without FMR, LVEDD ≥ 55 mm
• Ejection Fraction: ≥20 to ≤40%
• Symptom Status: NYHA II-IVa
• Patients to be considered for the present study will be required to have received all appropriate guidelines-recommended therapies for at least 3 months prior to the enrollment with stable doses of drugs for at least 1 month.
• Surgical risk:
  • For patients with FMR only: the Heart Team must assess as high-risk and may utilize risk score or comorbidities to demonstrate high risk features. High risk for mitral valve surgery is defined utilizing established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments) (MVARC Part 1)
  • For all patients: Subject is eligible for cardiac surgery (namely, the patient is in a condition that allows a potential conversion to open surgery in case of procedural complications). This criterion adds a safety level for the patients
• Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
• Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment