Clinical Trials
CHRISTINE E. LYNN HEART AND VASCULAR INSTITUTE

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HEART

DiagnosisInvestigator/SponsorProtocol Title & PurposeEligibility
Post-Coronary Artery Bypass SurgeryAlexander Kulik, MD, MPH, FRCSC
FACC, FAHA

Physician-Sponsored

American Heart Association
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency after Coronary Bypass?

The purpose of the study is to see if high-dose statin therapy will prevent the development of vein blockages (atherosclerosis) during the first year after coronary artery bypass graft surgery. (CABG)

http://www.clinicaltrials.gov/ct2/show/NCT01528709
Patients who have undergone coronary artery bypass surgery at Boca Raton Regional Hospital and that meet study specific qualifying criteria for enrollment. Enrollment will occur within 4 days from surgery.
Post-Coronary Artery Bypass SurgeryAlexander Kulik, MD, MPH, FRCSC
FACC, FAHA

Physician-Sponsored

AstraZeneca
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis (TARGET Trial): Does Ticagrelor Improve Graft Patency after Coronary Bypass?

The purpose of the study is to evaluate whether ticagrelor will help prevent the development of vein blockages after coronary bypass surgery, as compared to standard aspirin therapy.

https://www.clinicaltrials.gov/ct2/show/NCT02053909
Patients who have undergone coronary artery bypass surgery at Boca Raton Regional Hospital and that meet study specific qualifying criteria for enrollment. Enrollment will occur within 5 days from surgery.
Pre-existing Left Ventricular Systolic Dysfunction undergoing CABG with or without mitral valve surgery or isolated mitral valve surgeryAlexander Kulik, MD, MPH, FRCSC
FACC, FAHA

Oxygen Biotherapeutics
Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Study to Evaluate the Safety and Efficacy of Levosimendan in Cardiac Surgery Patients at High-Risk of Low Cardiac Output Syndrome (LCOS)

The purpose of the study is to evaluate the efficacy of Levosimendan compared with placebo, in reducing the 30-day composite event rate in subjects with reduced ejection fraction undergoing cardiac surgery on CPB.

http://clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=11
Patients who have planned cardiac surgery at Boca Raton Regional Hospital and meet study specific qualifying criteria for enrollment.
Pacemaker/defibrillator Martin Kloosterman, MD

Medtronic
Attain Performa™ Quadripolar Lead Clinical Study

The purpose of the Study is to evaluate the safety and efficacy of the Medtronic Attain Performa quadripolar, left ventricular pacing lead ("study lead") during and post the implant procedure.

http://clinicaltrials.gov/ct2/show/study/NCT01751022?term=attain+performa&rank=1&show_locs=Y#locn
Patients who receive cardiac resynchronization therapy at Boca Raton Regional Hospital.

VASCULAR

DiagnosisInvestigator/SponsorProtocol Title & PurposeEligibility
Aortic AneurysmsW. Anthony Lee, MD, FACS

Physician-Sponsored
The Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

The purpose of the study is to evaluate the use of branched endografts in the treatment of thoracoabdominal and suprarenal aortic aneurysms that cannot be treated using conventional stent grafts.

http://www.clinicaltrials.gov/ct2/show/NCT01524211
Diagnosis of a thoracoabdominal or suprarenal aortic aneurysm that requires repair and that meets study specific qualifying criteria for enrollment.
Aortic-iliac or iliac aneurysmsW. Anthony Lee, MD, FACS

Cook Incorporated
Clinical Study to Evaluate the Safety and Effectiveness of the Zenith Branch Endovascular Graft-Iliac Bifurcation System

The purpose of this study is to collect confirmatory safety and effectiveness data on the Zenith Branch Endovascular Graft-Iliac Bifurcation System in patients with aortic-iliac or iliac aneurysms.

http://www.clinicaltrials.gov/ct2/show/NCT01208415
Diagnosis of an aneurysm in the iliac arteries that requires repair and that meets study specific qualifying criteria for enrollment.
Abdominal Aortic AneurysmsW. Anthony Lee, MD, FACS

TriVascular Incorporated
The PMA Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent System

The purpose of this study is to demonstrate the long term safety and effectiveness of the Ovation/Ovation Prime Abdominal Stent Graft System for the endovascular-treatment of infrareneal abdominal aortic aneurysms in a post-approval environment.

http://clinicaltrials.gov/ct2/show/NCT01980901
Diagnosis of an aneurysm in the abdominal aorta that requires repair and that meets study specific qualifying criteria for enrollment.
Abdominal Aortic aneurysmsW. Anthony Lee, MD, FACS

Bolton Medical, Inc
A Phase II Clinical Study of the Safety and Performance of the Treovance Stent-Graft with Navitel Delivery System for Patients with Infrarenal Abdominal Aortic Aneurysms

The purpose of this study is to gather safety and effectiveness data on the Treovance Stent-Graft device in the treatment of patients with infrarenal abdominal aortic aneurysms.

https://clinicaltrials.gov/ct2/show/NCT02009644
Diagnosis of an aneurysm in the abdominal aorta that requires repair and that meets study specific qualifying criteria for enrollment.

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