EHMC IRB Study #: E-12-455

Principal Investigator:
Dr. Richard Goldweit
Tel: 201-569-4901
Email: drgoldweit@mac.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
National Heart, Lung and Blood Institute - Coordinating Center: New York University

Study Title:
ISCHEMIA: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches

Eligibility requirements:
Patients who are at least 18 years old with stable ischemic heart disease who receive a diagnosis of mild or moderate ischemia based on stress test imaging.

Study objectives:
To compare two standard approaches to treating ischemia: conservative (medicine and lifestyle changes) vs. invasive (cardiac catheterization with stenting or bypass plus medicine and lifestyle changes).

Procedures:
Patients will be randomized 1:1 to receive either the conservative or invasive treatment plan. All patients will then be followed via clinic visits and phone calls to provide lifestyle counseling, assess quality of life, and monitor for any future cardiac events.

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EHMC IRB Study #: E-11-434

Principal Investigator:
Dr. David Feigenblum
Tel: 201-894-3533
Email: feigenblum@yahoo.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
St. Jude Medical

Study Title:
Analyze: ST Monitoring to Detect ACS Events in ICD Patients

Eligibility requirements:
Patients who are at least 18 years old, have an indication for an ICD (Implantable Cardioverter-Defibrillator), and documented coronary artery disease.

Study objectives:
To demonstrate the safety and effectiveness of the Fortify ST ICD system (or other system with the ST Monitoring Feature) by analyzing the sensitivity of the feature to detect clinical events.

Procedures:
Patients will have the ST Monitoring Feature of their ICDs activated and programmed.  Each patient will receive a Merlin® @ home transmitter and will be enrolled in the Merlin.net System. This System allows the ICD to transmit ST (a segment of the EKG) information.  It can alert the patient or the patient's physician when any change occurs.

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EHMC IRB Study #: E-11-440

Principal Investigator:
Dr. David Feigenblum
Tel: 201-894-3533
Email: feigenblum@yahoo.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
Forest Research Institute, Inc.

Study Title:
AZM-MD-302: Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg AzimilideDihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Deaths in Patients with an ICD

Eligibility requirements:
Patients who are at least 18 years old with a left ventricular ejection fraction (LVEF) < 40%, have an ICD implanted, and have experienced a qualifying pre-implant cardiac event or post-implant shock.

Study objectives:
To assess the impact of 75 mg of Azimilide vs. placebo on the occurrence of unplanned cardiovascular hospitalizations, emergency room visits, or death in patients with an ICD.

Procedures:
Patients will be randomly assigned in a 1:1 ratio to receive 75 mg of Azimilide or placebo, and receive treatment for up to one (1) year.  Patients will be evaluated at screening, baseline, weeks 2, 4, 6, 8 and 10;  and then at months 3, 6, 9 and 12 or, at the withdrawal visit.  In addition, patients will be followed for 30 days after withdrawal.

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EHMC IRB Study #: E-10-387

Principal Investigator:
Dr. Grant Simons
Tel: 201-894-3533
Email: grant.simons@ehmc.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
TYRX Pharmaceutical

Study Title:
CENTURION: Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device (CRMD) Replacement with a Cardiac Resynchronization Therapy (CRT) Device - A Multicenter, Prospective Registry

Eligibility requirements:
Patients who are undergoing CRMD replacment with a CRT, with or without lead revisions/addition.

Study objectives:
To compare the incidence of infection during the first year after CRMD replacement with a CRT and the AIGISRx Anti-Bacterial Envelope or Custom Mesh, to the incidence in case-matched retrospective control patients who had a replacement with a CRT and no AIGISRx.

Procedures:
This is a prospective registry to collect information on the rate of infection during the first 12 months after implant with a CRT and AIGISRx.  Data will be collected from visits 1-8 weeks after the procedure, then at 3, 6, and 12 months after the procedure.

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EHMC IRB Study #: E-10-388

Principal Investigator:
Dr. Grant Simons
Tel: 201-894-3533
Email: grant.simons@ehmc.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
TYRX Pharmaceutical

Study Title:
CITADEL: AIGISRX Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device Replacement with an Implantable Cardioverter-Defibrillator (ICD) Citadel - A Multicenter, Prospective Registry

Eligibility requirements:
Patients who are undergoing CRMD replacment with an ICD, with or without lead revisions/addition

Study objectives:
To compare the incidence of infection during the first year after CRMD replacement with an ICD and the AIGISRx Anti-Bacterial Envelope or Custom Mesh, to the incidence in published control subjects who had a replacement with an ICD and no AIGISRx

Procedures:
This is a prospective registry to collect information on the rate of infection during the first 12 months after implant with a CRT and AIGISRx.  Data will be collected from visits 1-8 weeks after the procedure, then at 3, 6, and 12 months after the procedure.

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EHMC IRB Study #: E-10-397

Principal Investigator:
Dr. Grant Simons
Tel: 201-894-3533
Email: grant.simons@ehmc.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
Boston Scientific

Study Title:
PREVAIL: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy

Eligibility requirements:
Patients with atrial fibrillation who require treatment for potential clot formation and are eligible for warfarin (Coumadin) therapy.

Study objectives:
To provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Device as an alternative to warfarin therapy in patients with atrial fibrillation.

Procedures:
Patient will be randomized 2:1 to either receive the WATCHMAN device or warfarin therapy, respectively.  Patients randomized to WATCHMAN will receive warfarin therapy until imaging shows adequate sealing of the LAA (left atrial appendage.)  All patients will be followed at intervals of 45 days, 6 months, 9 months, 12 months, semi-annually for 3 years, then annually through 5 years.

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EHMC IRB Study #: E-07-297

Principal Investigator:
Dr. Richard Goldweit
Tel: 201-569-4901
Email: drgoldweit@mac.com

Study Coordinator:
Meryna Manandhar
Tel: 201-894-3907
Email: meryna.manandhar@ehmc.com

Sponsor:
Cordis Corporation

Study Title:
Sapphire WW: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy

Eligibility requirements:
High-risk surgical patients requiring intervention for obstructive carotid artery disease.

Study objectives:
To assess the outcomes of carotid stent-supported angioplasty in the treatment of obstructive carotid artery disease in high-surgical risk patients.

Procedures:
After the carotid stent-supported angioplasty procedure using , the patients will be evaluated prior to discharge, 30 days post-procedure, and 12 months post-procedure.  Evaluations will include blood tests, neurological examinations, and tracking of major side effects.

*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.

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