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Clinical Trials

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    Clinical Trials

  • Pima Heart and Vascular physicians are committed to finding new and innovative treatments that will help improve the quality of life for people with cardiovascular and venous disease. Highly regarded as leaders in their field, they are invited as key speakers for medical conferences and continuing medical education meetings across the world.

    As new treatments, systems, and devices are developed, several of the largest companies who develop these new technologies look to our physicians for testing and evaluation. Pima Heart and Vascular physicians have played a role in some of the most exciting breakthroughs over the past several years.

    Pima Heart and Vascular physicians continue their efforts in the discovery, development, and application of knowledge as it pertains to all areas of cardiovascular and venous disease with leadership and excellence to deliver quality healthcare services. As a patient, you’ll have the opportunity to participate in clinical trials and Pima Heart and Vascular has a dedicated Clinical Research Program following Institutional Review Board (IRB) and Good Clinical Practice guidelines.



    Clinical Research Video Series

    Watch our new 5 part video series and discover how our clinical research team pioneers new medical standards. At Pima Heart and Vascular, we offer hope through innovation. Welcome to our research journey.

    Welcome To Our Research Journey | Meet Monica Varela
    Welcome To Our Research...
    The Importance of Clinical Research | Dr. Scott Berman
    The Importance of Clinical...
    ​​Explore Cardiac Care with Dr. Peter Spooner | Clinical Research
    ​​Explore Cardiac Care...
    Heart Attack Survivor, Tim Spears | Clinical Research Patient Story
    Heart Attack Survivor, Tim...
    Clinical Research Panel Discussion | Dr. Greg Koshkarian
    Clinical Research Panel...
    ALLAY-HF Clinical Study | Pima Heart & Vascular
    ALLAY-HF Clinical Study |...

     


     

    Pima Heart and Vascular Partners

     


    Clinical Research & Trials

    What is clinical research? Clinical research is intended to help the medical field discover new ways to prevent and treat diseases. In addition, it assists in finding answers to questions about health, disease, and human behavior to develop new medicines and medical treatment. A clinical study involves research using human volunteers that is intended to add to medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. 

    Why clinical research? Through clinical research we gain insights and answers about the safety and effectiveness of drugs and other therapies. Clinical trials generate significant scientific data to validate the efficacy of an investigational device or investigational drug. Without clinical research, there would be no way to come up with solutions to test whether the new and innovative treatments are safe and how they work when given to patients. Clinical research opens doors to advancing prevention, treatments, and cures for diseases and disabilities.

    Different types of research? There are two types of clinical studies: clinical trials and observational studies. These types of clinical studies get categorized by phases. 

    Clinical Trials: In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators/study sponsor. These interventions may be medical products, such as drugs or devices; procedures; or modifications to a participants’ behavioral lifestyle. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other.

    Observational studies: In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator.

    Phases of clinical trials:

    Phase I: Is it safe?

    Phase II: Does it work?

    Phase III: Is it better than what we have now?

    Phase IV: What are possible long-term effects?

    Observational: How we may improve current health issues with data collected from a large groups of people?

     



    Clinical Trials Inquiry

    Fill out the form below for more information.

     



    Pima Heart and Vascular Clinical Trials Open to Enrollment

    Disease State: Heart Failure

    Allay-HF

    Official Study Name: Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in patients with Chronic Heart Failure.

    Principal Investigator: Dr. Thomas Waggoner

    Product: ALV1 system

    Patient Population: Patients with HF and preserved LVEF >50% or mid-range LVEF 40%<EF<50% will be evaluated for treatment via creation of a no-implant interarterial shunt.

    Alleviant ALLAY-HF Study


    Disease State: Heart Failure

    Optimizer-Post Approval Study

    Official Study Name: Optimizer Smart Post-Approval Study

    Principal Investigator: Dr. Darren Peress

    Product: Optimizer SMART Mini System

    Patient Population:Patients with Heart Failure Reduced Ejection Fraction of 25%-45%

    Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy – Full Text View – ClinicalTrials.gov


    Disease State: Heart Failure

    AIM HIGHER

    Official Study Name: Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction

    Principal Investigator: Dr. Darren Peress

    Sub-investigators: Dr. Lionel Faitelson Dr. Jitender Munjal

    Product: Optimizer Smart Mini System: Cardiac Contractility Modulation device

    Patient Population: An evaluation of cardiac contractility modulation therapy in patients with symptomatic heart failure with and a left ventricle ejection fraction of >40% and <60%.

    Assessment of CCM in HF With Higher Ejection Fraction – Full Text View – ClinicalTrials.gov


    Disease State: Heart Failure

    HYGEA – Google Trial with Wearable Technology

    Official Study Name: Transient Pulselessness Measurement using Smart Devices

    Principle Investigator: Dr. Jitender Munjal

    Sub-investigators: Dr. Neil Gheewala, Dr. Darren Peress

    Product: Pixel Smartwatch and Pixel Smartphone

    Patient Population: Patients that have a S-ICD placement with DFT and need DFT testing of a previously implanted device.


    Disease State: Recurrent Pericarditis

    Cardiol: Impact of CardiolRx on Recurrent Pericarditis

    Official Study Name: Impact of CardiolRxTM on Recurrent Pericarditis

    Product: CardiolRx (oral solution)

    Principle Investigator: Dr. Thomas Waggoner

    Patient Population: Patients with RP who are refractory or intolerant to current therapeutic management options or who require long-term corticosteroids.

    Primary Contact: Manuel Ortiz

    Impact of CardiolRxTM on Recurrent Pericarditis – Full Text View – ClinicalTrials.gov


    Disease State: Recurrent Pericarditis

    RESONANCE

    Official Study Name: Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients (RESONANCE)

    Principal Investigator: Dr. Thomas Waggoner

    Sub-Investigator: Dr. Greg Koshkarian

    Patient Population: Non-interventional registry trial for adult patients with active and inactive Recurrent Pericarditis to understand the natural history of RP and generate data on the impact and effectiveness of Rilonacept to treat RP.

    Registry Of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients – Full Text View – ClinicalTrials.gov


    Disease State: Cardiovascular Disease

    ABIOMED: LOQI Impella Registry

    Official Study Name: Long-Term Outcome and Quality Indicator (LOQI) Impella Registry

    Principal Investigator: Dr. Thomas Waggoner

    Product: Impella 

    Patient Population: This study will be capturing real world observational data of patients who have received or attempted to receive mechanical circulatory support via an impella device.

    Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study – Full Text View – ClinicalTrials.gov


    Disease State: Cardiovascular Disease

    Use of Impella ECP in Patients Undergoing an Elective or Urgent High-Risk PCI

    Official Study Name: ECP

    Principal Investigator: Dr. Thomas Waggoner

    Product: Impella ECP Pump System

    Patient Population: An evaluation of the rate of major adverse cardiovascular and cerebrovascular events with the Impella ECP in patient undergoing elective or urgent high-risk PCI

    Impella ECP Study (ECP Study) – Full Text View – ClinicalTrials.gov


    Disease State: Cardiovascular Disease

    DEFINE GPS

    Official Study Name: Distal Evaluation of Functional performance with Intravascular Sensors to assess the Narrowing Effect: Guided Physiologic Stenting

    Principal Investigator: Dr. Thomas Waggoner

    Sub-Investigators: Dr. Ajay Tuli, Dr. Janak Kansagra, Dr. Mukesh Gopalakrishnan, Dr. Nader Makki, Dr. Rajen Desai

    Product: iFR Co-registration with SyncVision 

    Patient Population: Patients having stable/unstable ischemic heart disease with an indication for a cardiac catheterization for diagnostic and/or treatment purposes.

    Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting – Full Text View – ClinicalTrials.gov


    Disease State: Venous Insufficiency

    US Post-Market Surveillance Study of the Surfacer System

    Official Study Name: US Post-Market Surveillance Study of the Surfacer® Inside-Out® Access Catheter System (Surfacer System)

    Principal Investigator: Dr. Dr. Scott Berman

    Sub-investigators: Dr. William Thomas

    Product: Surfacer® Inside-Out® Access Catheter System

    Patient Population: Patients that need central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

    US Post-Market Surveillance Study of the Surfacer System – Full Text View – ClinicalTrials.gov


    Disease State: Venous Insufficiency

    WAVE:

    Official Study Name: Prospective, Randomized, Controlled, Multicenter Study Comparing the Merit WRAPSODYTM Endovascular Stent Graft to Percutaneous Transluminal Angioplasty for Treatment of Venous Outflow

    Principal Investigator: Dr. Scott Berman

    Product: iFR Co-registration with SyncVision

    Patient Population: Patients having stable/unstable ischemic heart disease with an indication for a cardiac catheterization for diagnostic and/or treatment purposes


    Disease State: Carotid Artery Disease

    Roadster 3

    Official Study Name: Post Approval Study of Transcarotid artery revascularization in standard risk patients with significant carotid artery disease (Roadster 3)

    Principal Investigator: Dr. Scott Berman

    Product: Enroute TSS (trans carotid stent system) used in conjunction Enroute Neuroprotection system

    Patient Population: Patients receiving a carotid endarterectomy who require carotid revascularization

    Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease – Full Text View – ClinicalTrials.gov


    Disease State: Obstructive Hypertrophic Cardiomyopathy

    Bristol Myers Squib/IQVIA-Discover HCM

    Official Study Name: Deliver Insights in hypertrophic cardiomyopathy and observational outcomes in real world (DISCOVER-HCM): United States Prospective Registry Study

    Principal Investigator: Dr. Dr. Greg Koshkarian

    Sub-investigators: Dr. Ajay Tuli, Dr. Kioumars Mostafizi, Dr. Paul Bejarano, Dr. Gordon Watson

    Product: Mavacamten or normal standard of care beta blockers

    Patient Population:  Patients with symptomatic obstructive hypertrophic cardiomyopathy. The registry study will also provide a real-world understanding of the current obstructive HCM patient population, treatment patterns, and clinical relevant outcomes for patients with symptomatic obstructive HCM in the US.

    A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive HCM) – Full Text View – ClinicalTrials.gov


    Disease State: Hyperlipidemia

    AMGEN-Evolve MI

    Official Study Name: A Pragmatic Randomized multicenter trial of EVOLocumab Administered very early to reduce the risk of cardiovascular events in patients hospitalized with acute myocardial infarction

    Principal Investigator: Dr. Tuli

    Product: Repatha + routine lipid management vs. routine lipid management alone

    Patient Population: MI, acute care setting to be determined. Enrollment at onset of MI or within two weeks of event. Study will be long-term with further details to come, protocol pending. The goal of this study is aiming to aggressively lower LDL. Drug is not metabolized by kidneys or liver.

    EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction – Full Text View – ClinicalTrials.gov


    Disease State: Obesity

    Lily-GPIJ Trial for obesity

    Official Study Name: A Phase 3, randomized, double-blind, placebo-controlled study to investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults with obesity (SURMOUNT MMO)

    Principal Investigator: Dr. Koshkarian

    Product: Tirzepatide (weekly subcutaneous injection)

    Patient Population: People with obesity for BMI greater than or equal to 27 with a CVD risk or qualifying risk factors. Please see coordinator for further details.

    A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity – Full Text View – ClinicalTrials.gov


    Clinical Trials in Startup That Will Soon Begin Enrolling

    Disease State: Cardiovascular Disease

    Impact on Revascularization outcomes of ivus guided treatment of complex lesions and economic impact (IMPROVE)

    Official Study Name: IMRPOVE

    Principal Investigator: Dr. Joshua Balderman

    Product: Eagle Eye Platinum digital IVUS catheter with optional syncvision and Resolute Onyx Drug eluding stent vs angiographic guided PCI

    Patient Population: Patients undergoing complex pci

    IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact – Full Text View – ClinicalTrials.gov


    Disease State: Heart Failure

    INTEGRA-D 

    Official Study Name: Assessment of the Safety and Efficacy of a combine cardiac contractility modulation and implantable cardioverter defibrillator device for subjects with heart failure and reduced ejection fraction

    Principal Investigator:  Dr. Reddy

    Product: Optimizer Integra CCM-D system

    Patient Population: Implantable cardiac device system that combines CCM and ICD modules into one device for patients with heart failure and reduced ejection fraction (LVEF≤40 %)


    Disease State: Heart Failure

    PERFORMANCE

    Official Study Name: Protection against Emboli during caRotid artery stenting using a Neuroguard IEP® Direct 3-in-1 delivery system comprised oF a pOstdilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt III

    Principal Investigator: Dr. Bermar

    Product: Neuroguard IEP® Direct 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP® Direct System) and Neuroguard Direct Access Kit

    Patient Population: Symptomatic and asymptomatic subjects at high risk for adverse events from carotid endarterectomy (CEA) who require carotid revascularization.


    Disease State: Venous Insufficiency

    DEFIANCE

    Official Study Name: ClotTriever® Thrombectomy System vs. Anticoagulation alone for treatment of deep vein thrombosis

    Principal Investigator: Dr. Balderman 

    Product: ClotTriever® Thrombectomy System

    Patient Population: Patients with symptomatic unilateral iliofemoral DVT

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