StudyFinder
Randomized Clinical Evaluation of the AccuCinch Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)
Recruiting
The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
Male or Female
18 years and over
Inclusion Criteria:
• at least 18 years old
• Ejection Fraction: between 20% and 40% measured by transthoracic echocardiography (TTE)
• diagnosis and treatment for heart failure should be established at least 90 days before entering the study & should be on stable, optimal medical therapy for at least 30 days
Exclusion Criteria:
• myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
• any planned cardiac surgery or interventions within the next 180 days
• women who are pregnant, planning to become pregnant, or are breast feeding
• additional cardiac and medical diagnosis will exclude participation (study staff will review)
Device: AccuCinch Ventricular Restoration System, Drug: Guideline-Directed Medical Therapy
Heart & Vascular
Clinics and Surgery Center (CSC), Dilated Cardiomyopathy, Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)