Full Title: Randomized, Double-Blind, Placebo-Controlled Phase I/II Study of the Safety and Efficacy of Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With an Anterior Myocardial Infarction and Ischemic Left Ventricular Dysfunction (ALLogeneic Heart STem Cells to Achieve Myocardial Regeneration, ALLSTAR).
Sponsor: Capricor, Inc.
Primary Investigator: Kevin Silver, M.D.
Sub-Primary Investigator: Otto Costantini, M.D., Kenneth Berkovitz, M.D.
Primary Objective: To determine the safety profile of CAP-1002 administered by intracoronary infusion in patients with ischemic left ventricular dysfunction and a previous anterior myocardial infarction (MI).
Secondary Objective: To evaluate whether administration of CAP-1002 by intracoronary infusion may result in structural cardiac or functional clinical benefits for patients with ischemic left ventricular dysfunction and a previous anterior myocardial infarction (MI).
Full Title: A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure
Sponsor: Arca Biopharma
Principal Investigator: Otto Costantini, M.D.
Primary Objective: The primary objective of this study is to compare the effects of bucindolol and metoprolol on the recurrence of symptomatic AF/AFL in patients with HFREF who are β1389Arg/Arg homozygous and have undergone conversion to SR.
Secondary Objective: The secondary objective is to compare the effects of bucindolol and metoprolol on clinical outcomes and other electrocardiographic parameters in HFREF patients with AF/AFL who are β1389Arg/Arg homozygous and have undergone conversion to SR, and to assess the effects on rate control in patients who have developed permanent AF.
Full Title: CAPTure Information Via Automatic Threshold Evaluation
Sponsor: Boston Scientific
Primary Investigator: Pelini, M.D.
Sub-Primary Investigator: Otto Costantini, M.D., Kenneth Berkovitz, M.D.
Primary Objective: To evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold 9LVAT) features to support the regulatory approval of the AUTOGEN family of devices.
Full Title: A Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome.
Sponsor: Sanofi
Primary Investigator: Kevin Silver, M.D.
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with an LMT regimen that is statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, and optimized for long-term chronic use with other non-statin LMT(s) at Investigator’s discretion.
Secondary Objectives: The secondary objectives of this study include:
Full Title: Product Performance Platform – Product Surveillance Registry
Sponsor: Medtronic
Primary Investigator: Michael Pelini, M.D.
Product Performance Platform (PPP): The purpose of post-market surveillance is to “enhance the public health by real incidence of medical device adverse experiences.” The Product Performance sponsored by Medtronic, Inc. is designed to begin product performance as of market release using scientifically sound data to quickly identify product performance issues minimizing any negative impact on public health.
Studies conducted within the PPP are designed to collect data for the continuing periodic reporting on the safety, effectiveness and/or reliability of devices for their intended use. The PPP has a prospective, non-randomized design with multiple sites world-wide.
The PPP provides the infrastructure to support multiple product performance studies using a single data collection system, global of participating investigators and leveraging a common protocol. The PPP collects data prospectively which when combined with other produce performance activities, such as Returned Product Analysis, Medical Device Reporting, Vigilance Reporting, and the complaint registry, provides comprehensive information about potential system performance problems and their management.
Product Surveillance Registry (PSR):
The objective of the Product Surveillance Registry is to serve as an ongoing source of acute and chronic product performance, patient safety and clinical outcomes information associated with the use of market-released products.
The objectives of the study are to:
Full Title: S-ICD Post Approval Study
Sponsor: Boston Scientific
Primary Investigator: Michael Pelini, M.D.
Primary Objective: The primary objective of the S-ICD Post Approval Study is to document long-term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in commercial clinical subjects. Additional objectives include characterization of long-term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented subject populations, such as women and African-Americans.
