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Clinical Research Trials

The Levinson Heart Hospital is committed to offering our patients opportunities to participate in new clinical research trials. This is part of our mission in offering the most advanced services available. These trials are open to those who qualify. Our research nurse coordinators will work with your physicians to discuss trials with you and your family. To learn more about these or other clinical research trials, please speak with your physician. Studies opened and managed by organizations as noted below.

1.

Investigational Product V710

A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nl Staphylococcus aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery; IND 12,714; CJW2007-016

This study is being performed to assess the efficacy of a single dose of V710 vaccine to prevent serious S. aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

Study Sponsor: Merck
Participating Institutions: Cardiothoracic Surgical Associates and CJW Medical Center
Contact Information: Margaret Wittenbraker ACNP, Study Coordinator (804) 320-2751

2.

Protocol# P05633: The Effect of Acadesine on Clinically Significant Adverse Cardiovascular and Cerebrovascular Events in High-Risk Subjects Undergoing Coronary Bypass: RED-CABG Trial (Reduction in Cardiovascular Events by Acadesine in Subjects Undergoing CABG), IND 34,112; CJW2009-01

The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk patients undergoing CABG surgery.

Study Sponsor: Schering-Plough
Participating Institutions: Cardiothoracic Surgical Associates and CJW Medical Center
Contact Information: Margaret Wittenbraker ACNP, Study Coordinator (804) 320-2751

3.

ST Segment Detection Study, IDE G070210; CJW2008-012

The purpose of the ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.

Study Sponsor: Medtronic Cardiac Rhythm Disease Management
Participating Institutions: Virginia Cardiovascular Specialists and CJW Medical Center
Contact Information: Leslie Stone RN, Study Coordinator (804) 323-5011

4.

Protocol# P-2611; Carotid Revascularization with ev3 Arterial Technology Evolution Post Approval Study; CREATE PAS, P060001; CJW2007-009

The purposes of this study are:

  • To confirm the PROTÉGÉ ® GPS™ and PROTÉGÉ® RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device are safe and effective in the treatment of carotid artery stenosis for subjects with a high risk for complications during carotid endarterectomy.
  • To evaluate rare and unanticipated adverse events.
  • To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Study Sponsor: ev3 Endovascular, Inc
Participating Institutions: Virginia Cardiovascular Specialists and CJW Medical Center
Contact Information: Kathleen Turner RN, Study Coordinator (804) 282-2685