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Education
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Research
Heart Consultants, PC is involved in many research projects with various companies which are listed below.
OMNI Study
Purpose: This trial 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 PainFree Programming, and the disease management diagnostic, OptiVol. The OMNI study will also gather data on clinical profiles, clinical management and follow-up practices.
Sponsor: Medtronic Corporation
PREFER Study
Purpose: The primary purpose of the Medtronic PREFER study: Pacemaker Remote Follow-up Evaluation and Review is to demonstrate that using the Medtronic CareLink Network to facilitate management of pacemaker patients leads to improved clinical outcomes of pacemaker patients over current patient management practices.
Sponsor: Medtronic Corporation
TRENDS study
Purpose:This trial is a prospective, non-randomized, multi-center study in subjects implanted with a commercially available Medtronic implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. The primary purpose of the trial is to determine if the device trending data are indicators of clinical outcomes in subjects with atrial tachyarrhythmia’s. Primary objective of the study is to determine if AT/AF burden over 30 days is an independent predictor of occurrences of study endpoint events; ischemic stroke, transient ischemic attacks (TIA) of non-stroke systemic embolism in subjects not receiving anticoagulation therapy.
Sponsor: Medtronic Corporation
RIGHT Study
Purpose: This trial is a randomized, prospective, two-arm study that will assess the differential efficacy of the Guidant ICDs using Rhythm ID versus competitive Medtronic ICDs with Enhanced PR Logic or Wavelet discrimination algorithms. It will compare the incidence of VT/VF therapies delivered for SVT episodes using Guidant devices with Rhythm ID to that of Medtronic devices employing Medtronic’s rhythm discrimination algorithms, Enhanced PR Logic (dual chamber devices) and Wavelet (single chamber devices).
Sponsor: Guidant Corporation
PEGASUS CRT Study
Purpose: This trial is a randomized, prospective, single blind, three-arm study that will assess the effect of a CRT defibrillator (CRT-D) programmed to DDD-70 or DDDR-40 compared to DDD-40. Clinical efficacy will be assessed by evaluation the effect of pacing mode on a clinical composite score. Other prospectively defined endpoints will be changes in clinical outcomes including, quality of life, physical activity, atrial arrhythmia burden, cardiovascular medication and programming changes/crossover.
Sponsor: Guidant Corporation
LANDIT Study
Purpose: This trial 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.
Sponsor: St Jude Medical
OPTIMUM Study
Purpose: This trial 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 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 events. The registry will also evaluate the chronic electrical and mechanical performance of the Optim ™ leads.
Sponsor: St. Jude Medical