Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study
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|ClinicalTrials.gov Identifier: NCT03183895|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : August 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiomyopathies||Device: Left ventricular restoration||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Performance Evaluation of 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 CorCinch-EU Study|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||March 2027|
- Device: Left ventricular restoration
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.
- Safety outcome: 30-day major adverse events (MAEs) [ Time Frame: 30-day ]
Major adverse event (MAE) where MAE is a composite of the following device- or procedure-related events:
A. All-cause mortality
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
- 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 [ Time Frame: 30-day ]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.
- Structural performance: Assessment of device integrity [ Time Frame: 30-day ]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)
- Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition [ Time Frame: 30-day ]Freedom from re-hospitalizations or re-interventions for the underlying condition
- Clinical outcome: Improvement in NYHA functional class [ Time Frame: 30-day ]Improvement in NYHA functional class when compared to baseline assessment
- Clinical outcome: Improvement in six-minute walk test [ Time Frame: 30-day ]Improvement in six-minute walk test (6MWT) when compared to baseline assessment
- Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) [ Time Frame: 30-day ]Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) when compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183895
|Contact: Michael Zapien, MS, CCRA||408-727-1105 ext email@example.com|
|Contact: Judit Adorjánfirstname.lastname@example.org|
|Study Director:||Michael Zapien, MS, CCRA||Ancora Heart, Inc.|