Heart Disease Clinical Trials

Multi-center, prospective, single-arm, continued access study of the Optimizer Smart System with CCM therapy. All subjects will be followed until the PMA order has been issued by the FDA. The protocol is designed to collect adverse safety events, quality of life data and data needed for comparison with long term ...

Use of Vector Velocity Imaging (VVI)/left ventricular circumferential(LVC) and/or radial strain analysis(RSA) to optimize left ventricular synchrony in patients receiving cardiac resynchronization therapy(CRT). VVI Optimize Registry is a prospective registry that will collect information regarding the natural history, health care interactions, clinical/health outcomes, and the methods of treatment of participants ...

II. BACKGROUND INFORMATION A. Name and description of investigational product The investigational product is the OPTIMIZER IVs System, a system capable of delivering non-excitatory cardiac contractility modulation (CCM) signals. These electrical signals are intended to influence myocardial properties in patients with chronic heart failure. The System consists of five major ...

1. Background 1.1. Antiplatelet therapy after acute myocardial infarction Dual antiplatelet therapy with aspirin, combined with a P2Y12 receptor inhibitor, is a cornerstone of therapy for acute myocardial infarction (AMI). Treatment with clopidogrel in addition to aspirin resulted in a 20% reduction in major adverse cardiovascular events (MACE) when compared ...

1.0 INTRODUCTION CardioKinetix has developed a catheter-based treatment for patients with left ventricular dilation after an anterior MI. The implantable device, called the Parachute Implant, is a partitioning membrane deployed within the compromised ventricle. The Parachute Implant isolates the dysfunctional region of the ventricle and decreases functional chamber volume. 1.1 ...

Since 2002, wearable cardioverter defibrillators (WCD) have been approved for use in the USA and Europe to prevent sudden death due to rapid abnormal rhythms of the heart. In this particular model, more data is collected and additional options are available that may help in the monitoring and treatment of ...

CRT implant strategy using the longest electrical delay for non-left bundle branch block patients (Enhance CRT). 

A research study is comparing the effects of an investigational combination therapy to the effects of these medications alone, and compared to placebo. This research study may be an option if you: Are at least 18 years of age Are on a maximally tolerated statin therapy and have been told ...

A clinical trial seeking patients for a research study for the treatment of Hypertriglyceridemia. The purpose of this study is test the safety and effectiveness of a study drug to a comparator and that of a placebo. Volunteers may receive compensation up to $625 for time, travel and study-related medical ...

The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6MWD from Baseline to Week 24 in subjects with PH associated with HFpEF. There are no approved treatments for PH in subjects with ...