This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy
The primary objectives of this study are to evaluate the safety and performance of the AccuCinch Ventricular Repair System for the treatment of heart failure and functional mitral regurgitation in symptomatic adult patients with or without functional mitral regurgitation (FMR) and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who remain symptomatic despite optimized medical therapy. Subjects with FMR must present with at least moderate FMR, a reduced ejection fraction (≤40%) and high operative risk as assessed by the Heart Team. The Heart Team may utilize 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). Subjects without FMR must present a markedly dilated left ventricle with LVEDD ≥ 55 mm and reduced ejection fraction (≤40%). These patients are not potential candidates for "conventional intervention", because their mitral valve is not in need of repair or replacement. Therefore, AccuCinch represents the sole treatment option for these patients, who are not selected on the basis of high surgical risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.
Republican Scientific and Practical Centre of Cardiology
Minsk, Belarus
Onze Lieve Vrouwziekenhuis
Aalst, Aaslt, Belgium
Safety outcome: 30-day major adverse events (MAEs)
Major adverse event (MAE) where MAE is a composite of the following device- or procedure-related events: A. All-cause mortality B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Myocardial infarction or coronary ischemia requiring PCI or CABG G. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. I. Emergency surgery or re-intervention related to the device or access procedure
Time frame: 30-day
Technical success: Successful access, delivery, and retrieval of AccuCinch System components, successful deployment of the AccuCinch implant without need for unplanned or emergency surgery or re-intervention
Successful access, delivery, and retrieval of all AccuCinch catheters. Deployment and correct positioning of the intended AccuCinch implant, and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure measured upon completion of the procedure.
Time frame: 30-day
Structural performance: Assessment of device integrity
No migration, embolization, detachment, fracture, hemolysis, thrombosis or endocarditis; and no para-device complications (erosion, effusion requiring surgery or drainage or producing tamponade, damage to the MV apparatus)
Time frame: 30-day
Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition
Freedom from re-hospitalizations or re-interventions for the underlying condition
Time frame: 30-day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AZ Sint-Jan Brugge
Bruges, Belgium
Na Homolce Hospital
Prague, Czechia
Pessac (CHU Bordeaux)
Pessac, Avenue Magellen, France
Hôpital Cardio-Vasculaire Louis Pradel
Bron, France
Hôpital de La Timone
Marseille, France
Paris Hôpital de la Pitié-Salpêtrière
Paris, France
Hôpital Civil de Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, France
...and 9 more locations
Clinical outcome: Improvement in NYHA functional class
Improvement in NYHA functional class when compared to baseline assessment
Time frame: 30-day
Clinical outcome: Improvement in six-minute walk test
Improvement in six-minute walk test (6MWT) when compared to baseline assessment
Time frame: 30-day
Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL)
Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) when compared to baseline
Time frame: 30-day