Clinical Trials

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5 studies in Division of Cardiovascular Diseases in Phoenix/Scottsdale, AZ.

  1. A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

    Phoenix/Scottsdale, Ariz., Rochester, Minn. View Summary

    A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

    Location:

    Phoenix/Scottsdale, Ariz., Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy).

    NCT ID:

    NCT01966458

    IRB Number:

    13-006972

    Who can I contact for additional information about this study?

    Rochester: Cathy Anderson Severson 507-255-2673
                        
    Scottsdale: Marlene Lind
                        

  2. A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

    Phoenix/Scottsdale, Ariz. View Summary

    A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.

    NCT ID:

    NCT01764633

    IRB Number:

    12-005115

    Who can I contact for additional information about this study?

  3. Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification

    Phoenix/Scottsdale, Ariz. View Summary

    Assessment of Myocardial Tissue Damage in Aortic Stenosis for Risk Stratification

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image analysis of integrated backscatter (IB), which can express changes in myocardial tissue composition (amount of fibrosis) based on its ultrasound reflectivity, global left ventricular (LV) load as measured by Zva, and ECG analysis of the duration of the QRS interval have a role in risk stratification for AS patients and to apply those methods to identify which patients would benefit from surgical intervention. The investigators hypothesize that 1) the severity of myocardial damage can discriminate the prognosis in patients with AS, and 2) IB, Zva, and QRS interval can be diagnostic measures of the severity of myocardial damage. The investigators will measure the severity of myocardial fibrosis using MRI (reference) in 50 patients and will test the diagnostic significance of IB (testing method). Zva, QRS duration, and conventional echocardiographic measures will also be tested for diagnosing severity of myocardial fibrosis.

    NCT ID:

    NCT02101619

    IRB Number:

    13-004385

    Who can I contact for additional information about this study?


    Scottsdale: Minako Katayama, MD 480-301-9063
                        

  4. MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Phoenix/Scottsdale, Ariz. View Summary

    MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The primary objective of this study is to evaluate the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average per patient number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure, over the 12 months following administration of investigational product (IP).

    NCT ID:

    NCT01670981

    IRB Number:

    13-001455

    Who can I contact for additional information about this study?

    Rochester: Bola Aduloju, RN 507-255-2831
                        Cindy M. Woltman, RN 507-266-4095
    Scottsdale: Barbara Knight 480-342-2545
                        
    Jacksonville: Estela Staggs 904-953-8509
                        
  5. Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

    NCT ID:

    NCT00911508

    IRB Number:

    09-004616

    Who can I contact for additional information about this study?

    Rochester: HRS Research Office 507-255-7456