CAP 2

Name of Research Study:

The Continued Access to PREVAIL (CAP2)

Study Doctor:

Kelly Tucker, M.D. & Jay Lee, M.D.

Description:

After the successful FDA Approval of the WATCHMAN Device, the Orange County Heart Institute is continuing to follow up on the effectiveness of the site. This study is a prospective, non-randomized, multicenter study to allow continued access to the WATCHMAN LAA Closure Technology during the data analysis reporting and review of the PREVAIL pivotal study Pre-Market Application by the FDA.

CIRT

Name of Research Study:

Cardiovascular Inflammation Reduction Trial

Study Doctor:

Lawrence Santora MD, FACC

Description:

A randomized, double-blind, placebo-controlled, event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of cardiovascular events among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome

Doctors have noticed that patients taking methotrexate for their arthritis seem to have less of the diseases caused by clogging of the arteries. We would like to find out if methotrexate reduces the chance of heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome who have already had at least one heart attack or have major blockages in more than one coronary artery found on a heart catheterization.

Eligibility: You may be eligible if you have had a heart attack or have major blockages in more than one coronary artery found on a heart catheterization within the past 5 years and have either type 2 diabetes or metabolic syndrome.

CIRT
Doctors have noticed that patients taking methotrexate for their arthritis seem to have less of the diseases caused by clogging of the arteries.

TEVA

Name of Research Study:

A Double-blind, Randomized, Sham-procedure-controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (REXLEMESTROCEL-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1

Study Doctor:

Kelly J. Tucker, MD

Description:

You are being asked to take part in this study because you have heart failure symptoms, despite being treated with all appropriate medications. Most subjects who have heart failure have permanent (not reversible) damage to the function of their heart muscle. Currently there are no available therapies that are able to restore the function of damaged heart muscle. Even though the blood vessels in your heart may be open, you are eligible for this study because there is enough damage to your heart and your heart is not functioning normally.

This is a study of an experimental study product cells called REXLEMESTROCEL-L, which consists of Mesenchymal Precursor Cells (or MPCs). These cells are special cells that were obtained from the bone marrow of a healthy person or donor who donated bone marrow for the purpose of this study.

The purpose of this study is to determine if the injection of the cells into your heart muscle with a specific type of needle can help restore heart muscle function. This study will look at the safety and effectiveness of injecting these cells into the heart muscle when compared to a sham procedure where no cells will be injected.

Eligibility: Screening for this study is very comprehensive. To be eligible, you must either have had a hospitalized for Heart Failure, or Pro-BNP levels over 1000 mg/dL.

TEVA
Currently there are no available therapies that are able to restore the function of damaged heart muscle.