Research

Device Studies

OMNI Study
Purpose: This study is a post market observational multi-center study. The primary purpose is to characterize therapy and diagnostic utilization in study participants implanted with study devices and to describe implantable cardioverter defibrillator (ICD) therapy utilization for life threatening arrhythmias in primary and secondary prevention study participants. The focus will be on the therapies of Managed Ventricular Pacing (MVP), Medtronic Pain Free Programming, and the disease management diagnostic, OptiVol. The OMNI study will also gather data on clinical profiles, clinical management and follow-up practices.

Study Duration: 5 years
Patients Enrolled: 18
Study is Closed to Enrollment
HCPC Participating Sites: Immanuel, Westroads, Fremont, Norfolk

Sponsor: Medtronic Corporation

LANDIT Study
Purpose: This study is a prospective, multi-center, data collection registry. The primary purpose of the study is to produce an outcome-oriented registry of patients implanted with a St Jude Medical Cardiac Resynchronization device. This registry will evaluate usage patterns of left ventricular leads and delivery systems during Cardiac Resynchronization Therapy device implantation. In addition, this registry will generate an image library of coronary vein anatomy that can be used to correlate left ventricular leads and the Cardiac Positioning Delivery System selection with patient anatomy and implantation success rates. Study Duration: 3 years
Patients Enrolled: 57
Study is Open to Enrollment
HCPC Participating Sites: Immanuel, Westroads, Fremont, Norfolk

Sponsor: St Jude Medical

OPTIMUM Study
Purpose: This study is a multi-center, data collection registry. The primary purpose of the study is to produce an outcome-oriented registry of patients implanted with St. Jude Medical OPTIM leads. This registry will evaluate the chronic clinical performance of the market released St. Jude Medical Cardiac Rhythm Management leads with Optim insulation material, in terms of survival from any insulation related adverse event. The registry will also evaluate the chronic electrical and mechanical performance of the Optim leads. Study Duration: 5 years
Patients Enrolled: 62
Study is Open to Enrollment
HCPC Participating Sites: Immanuel, Westroads, Fremont, Norfolk, Lakeside

Sponsor: St. Jude Medical

PROVIDE Study
Purpose: This study is a prospective randomized, multi-center study using a market-released SJM ICD or CRT-D device. The purpose of the study is to evaluate the effectiveness of programming specific detection and therapy criteria in prolonging the time to first shock, without increasing arrhythmic syncope, in the primary prevention ICD CRT-D population. The primary endpoint of this study is the rate of first shock and the primary safety endpoint is the rate of arrhythmic syncope. Additional data will be collected including; shocks, all-cause, inappropriate therapies, inappropriate SVT detections, untreated sustained VT/VF, VT episodes accelerating to VF, success of ATP therapies, health care utilization (hospitalization, ER or clinic visits) due to any ICD related events. Study Duration: 3 Years
Patients Enrolled: 8
Study is Open to Enrollment
HCPC Participating Sites: Immanuel, Lakeside, Fremont, Westroads

Sponsor: St. Jude Medical

REPLACE Study
Purpose: This study is a prospective, multi-center registry, which will focus on patients scheduled for a generator replacement procedure. The registry will assess the all-cause complications related to the replacement procedure. This will include; patients with a planned system modification and patients without a planned system modification. Evaluation of the influence of baseline variables contributing to the all-cause complication rates will be included. Study Duration: 2 years
Patients Enrolled: 18
Study is Closed to Enrollment
HCPC Participating Sites: Immanuel, Westroads

Sponsor: Biotronic

Clinical Studies Currently Enrolling Patients:

TRACER – Thrombin Receptor Antagonist for Clinical Events Reduction

HCPC Site	Principal Investigator	Study Coordinator
Fremont	Dr. Douglas M. Guy	Keri Miller, PA-C
Lakeside	Dr. Sherrill K. Murphy	Barbara Roessner, PA-C
Immanuel	Dr. Michael M. Dehning	Sheri Rowland, APRN-C
Westroads	Dr. Charles E. Olson	Starla Lynch, RN

Sponsor: Schering-Plough Research Institute and Duke Clinical Research Institute

Phase III Study

Description of Study: The TRACER Trial is a multi-center, randomized study enrolling patients with non ST segment elevation acute coronary syndromes (unstable angina or non-ST elevation MI). Patients will be randomized to either placebo plus standard medical care (including aspirin and clopidogrel) or to TRA(SCH 530348 ) once daily plus standard medical care in a blinded fashion. The Phase III TRACER ACS trial will use an oral 40 mg loading dose and a daily 2.5 mg maintenance dose. The SCH 530348 is an investigational compound which inhibits the most potent stimulus of platelet activation, thrombin, which is a driver of the clotting process.

Approximately 10,000 Patients will be enrolled at approximately 800 centers in more than 30 countries worldwide including Asia, Europe, Latin America and North America. The primary endpoint of the Phase III TRACER trial is the composite of cardiovascular death, MI, rehospitalization for ACS, urgent coronary revascularization or stroke.

The follow up visits in the first year are at 30 Days, 4, 8, and 12 Months (4 Visits) then every 6 Months thereafter until study is completed. The study will be considered completed when the last patient enrolled has been followed for 1 Year.

ARISTOTLE - Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation

HCPC Site	Principal Investigator	Study Coordinator
Immanuel	Dr. Jeffrey M. Mahoney	Sheri Rowland, APRN-C

Sponsor: Bristol-Myers Squibb and Duke Clinical Research Institute

Phase III Study

Description of Study: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of Apixaban In Preventing Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation. The study will be conducted in approximately 800 sites in North and South America, Europe, Australia and Asia. The primary objective is to determine if apixaban is noninferior to warfarin (INR target range 2.0 - 3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at least one additional risk factor for stroke. Subjects will receive active apixaban tablets and placebo warfarin tablets or placebo apixaban tablets and active warfarin tablets. Study visits will occur monthly for INR monitoring. At the INR visits, only INR monitoring, assessment of outcomes, assessment of AEs, and assessment of study medication compliance will be performed. In addition, at the quarterly visits during the treatment period (Months 3, 6, 9, 15, 18,21, 27, 30 and 33) assessment of changes in concomitant medications, vital signs and laboratory assessments will be performed and at the yearly visits during the treatment period (Months 12, 24 and 36)physical measurements, and 12 lead ECGs will be obtained. All subjects will be followed for the development of stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction, death, bleeding, hospitalization or treatment discontinuation until the end of the study.

ICE T – TIMI 49 – Low Dose IntraCoronary AdjunctivE Tenecteplase During Primary PCI for ST-Elevation Myocardial Infarction

HCPC Site	Principal Investigator	Study Coordinator
Fremont	Dr. Douglas M. Guy	Ami Jones, PA-C

Sponsor: Schering-Plough Research Institute and Duke Clinical Research Institute

Phase III Study

Description of Study: : This is a randomized, open-label, multicenter, placebo-controlled pilot trial to evaluate the feasibility and safety of low-dose IC tenecteplase administered as adjunctive therapy to aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibition during primary PCI for STEMI. Forty subjects at approximately 8 sites will be randomized 1:1 to treatment of the infarct-related artery with low-dose IC tenecteplase or saline placebo (20 subjects in each arm).

The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of administration of low-dose adjunctive IC tenecteplase compared to the administration of IC saline placebo during primary PCI. Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery.

Clinical outcomes will be assessed in each subject through hospital discharge and 30 days. The total enrollment phase is estimated to be approximately 1 year.