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Clinical Trials at Englewood Hospital: Cardiology

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EHMC IRB Study #:E-13-518

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:
Hansen Medical, Inc.

Study Title:
A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning the ThermoCool® Catheter in Subjects with Paroxysmal Atrial Fibrillation.

Eligibility requirements:
All patients must be > 18 years old with paroxysmal atrial fibrillation that has not responded to at least one anti-arrhythmic drug. Patients must be willing and able to undergo catheter ablation.

Study objectives:
This IDE study is to evaluate the safety and effectiveness rate for the Biosense NaviStar® ThermoCool® catheter remotely introduced and positioned through the family of Artisan guide catheters.

Procedures:

Eligible patients will undergo a catheter ablation utilizing the Sensei X Robotic Catheter System and the family of Artisan guide catheters for introducing and positioning of the ThermoCool catheter. After the ablation, data on the safety and efficacy of the procedure will be collected. Subjects will have follow up evaluation at the following time points: discharge, 7 days, 30 days, 90 days, 180 days, and 360 days after the ablation.

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EHMC IRB Study #:E-13-509

Principal Investigator: 
Dr. Joseph DeGregorio
Tel: 201-894-2880
Email: joseph.degregorio@ehmc.com

Study Coordinator: 
Neha Kalra
Tel: 201-894-2107
Email: Email: neha.kalra@ehmc.com

Sponsor:
Abbott Cardiovascular

Study Title:
ABSORB

Eligibility requirements:

All patients must be > 18 years old, have evidence of myocardial ischemia with an ejection fraction > 30%, and no prior acute myocardial infarction or STEMI/NSTEMI to consent to participate.

Once consented, the diagnostic angiogram must reveal one or two de novo lesions of appropriate size to continue on to randomization in the study. 

Study objectives:

This IDE study is to evaluate the safety and effectiveness of the Absorb BVS System (bioresorbable stent) compared to the XIENCE (metallic stent) in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Procedures:

All patients will be prepared as per the standard of care for interventional cardiology subjects.  Prior to the procedure all subjects will be offered participation in this study.

If a patient consents, during the intervention, if qualifying lesions are identified, then the patient will be randomized 2:1 to receive the ABSORB BVS vs. the XIENCE device.

This is a single-blind study so subjects will not be told what device they received.  All subjects will be required to complete Quality of Life questionnaires periodically throughout the study.

Subjects will be required to take anti-platelet medication as per standard of care for any stent placement, and be followed for five years post intervention

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EHMC IRB Study #:E-13-497

Principal Investigator: 
Dr. David Feigenblum
Tel: 201-569-4901
Email: feigenblum@yahoo.com

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

Sponsor:
St. Jude Medical

Study Title:
MULTIPOINT™ PACING (MPP) IDE STUDY

Eligibility requirements:
All patients must be > 18 years old and have a clinical indication for implantation of a CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s). To be eligible, patients cannot have a prior LV placement.

Study objectives:

This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months.  

Procedures:

The implant procedure will be performed according to standard of care.  The final LV pacing configuration is programmed using any one of the 10 available pacing vectors.  Patients will continue to receive BiV therapy until the 3-month follow-up visit.  At the 3-month visit, responder status will be assessed and only patients with “equal or better” echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms – the (1) BiV arm or the (2) MPP arm.  Final programming in both arms will be performed as follows: (1) MPP arm: the physician will program MPP using any combination that yields “equal or better” acute hemodynamics compared to BiV pacing.  (2) BiV arm: the final BiV programming will be left up to the physician's discretion.  All patients will continue to be followed up at 6 and 9 months, and every 6 months thereafter until the end of the study.  At the 9-month visit, responder status will be evaluated once again and compared to the status at 3 months, for the evaluation of the primary efficacy endpoint.

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EHMC IRB Study #:E-12-467


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:
CAP2: Continued Access to PREVAIL

Eligibility requirements:
Patients who are at least 18 years old with atrial fibrillation who can tolerate long-term warfarin therapy, but can discontinue it if WATCHMAN device implanted successfully

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:

All patients will receive the WATCHMAN LAA device while receiving warfarin therapy. Patients will also be required to take aspirin and continue warfarin after the implant until at least the 45 day visit. If the 45-day echo shows adequate seal of the appendage, then warfarin therapy will be discontinued but aspirin will be continued indefinitely. Clopidogrel (Plavix) will also be given from the 45-day visit until the 6 month visit. Patients will then be followed at 12, 18, 24, 30, 36, 48, and 60 months after the implant.

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EHMC IRB Study #:E-13-465

Principal Investigator: 
Dr. Jay Erlebacher
Tel: 201-569-4901
Email: drerle@mac.com

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

Sponsor:
Medtronic

Study Title:
REVEAL AF

Eligibility requirements:

Patients 18 years of age or older, who are suspected of having Atrial Fibrillation (AF) or at risk of having AF based on symptoms and/or patient population characteristics.

Patients must not have a history of AF, atrial flutter or hemorrhagic stroke.  No ischemic stroke or TIA within 1 year of enrollment.  No heart attack or heart surgery within 90 days of enrollment.  

Study objectives:

To determine the prevalence of an AF episode lasting for 6 minutes or more in patients who are at risk of having AF and also identify incidences that can predict  AF onset in these patients.

Information will also be gained as to how physicians manage these patients once AF is detected.  This study will also explore the Quality of life issues, AF burden over time and determine how patients at high risk of having AF utilize the healthcare that is available to them.

Procedures:

All patients will receive and be continually monitored by a REVEAL implantable cardiac monitor (ICM) for the incidence of AF in patients at high risk of developing AF.  

Patients will be required to have their device interrogated every month to transmit data over the Medtronic CareLink network for the detection of AF.  

There will be scheduled follow up doctor visits at 6, 12 and 18 months after successful implant.  Patients will be monitored for a minimum of 18 months and a maximum of 30 months after implantation of the REVEAL cardiac monitor.

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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-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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