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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.

    For more information, contact us at aleksander.herber@pimaheartandvascular.com.


    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?


    Pima Heart and Vascular Clinical Trials Open to Enrollment

    Novartis-Study of Inclisiran to Prevent CV events in participants with established CV disease

    Principal Investigator: Dr. Ajay Tuli

    Sub-investigators:Dr. Thomas Waggoner, Dr. Gregory Koshkarian, Dr. Mukesh Gopalakrishnan, Dr. Janak Kansagra

    Product: Inclisiran vs placebo

    Patient population: Patient population: Patients with established atherosclerotic cardiovascular disease will be given inclisiran or a placebo to evaluate the benefits of inclisiran on major adverse cardiovascular events.

    Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease – Full Text View – ClinicalTrials.gov


    SAVVE:

    Principal Investigator: Dr. Scott Berman

    Sub-investigators: Dr. Joshua Balderman, Dr. Luis Leon, Dr. John Pacanowski, Jennifer Clark PA, Dr. Joseph Sabat

    Product: Bioprosthetic Venovalve

    Patient Population: Adult patients with deep venous valvular insufficiency are provided with a functional venovalve that reduces the reflux of blood in the lower extremity veins.

    The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study – Full Text View – ClinicalTrials.gov


    Lily-Relaxin trial-EZDB

    Principal Investigator: Dr. Nader Makki

    Sub-investigators: Dr. Gregory Koshkarian, Dr. Thomas Waggoner

    Product: LY3540378 (weekly subcutaneous injection)

    Patient Population: Heart Failure patients with preserved ejection fraction ≥ 50%, with a recent hospitalization in the last two weeks that required two doses of IV lasik at the time of hospitalization.

    A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) – Full Text View – ClinicalTrials.gov


    LOQI Impella Registry

    Principal Investigator: Dr. Dr. Thomas Waggoner

    Sub-investigators: Dr. William Thomas

    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


    US Post-Market Surveillance Study of the 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 method.

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


    Bristol Myers Squib/IQVIA-Discover HCM

    Principal Investigator: Dr. Dr. Greg Koshkarian

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

    Product: Mavacamten vs other available medical therapies

    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 clinically 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


    Roadster

    Principal Investigator: Dr. Scott Berman

    Sub-investigators: Dr. Luis Leon, Dr. Joshua Balderman, Dr. Joseph Sabat, Dr. Bernardo Mendoza

    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


    AIM HIGHER

    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


    Optimizer-Post Approval Study

    Principal Investigator: Dr. Darren Peress

    Product: Optimizer SMART Mini System: Cardiac Contractility Modulation device

    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


    SAFE MCS

    Principal Investigator: Dr. Thomas Waggoner

    Product: Saranas Early Bird System: Bleeding Monitoring Device

    Patient Population: An evaluation of a bleeding monitoring device system for patients undergoing complex high-risk PCI with mechanical circulatory support via Impella and transfemoral arterial approach.

    Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System – Full Text View – ClinicalTrials.gov


    VENASEAL

    Principal Investigator: Dr. Joshua Balderman

    Sub-Investigators: Dr. Joseph Sabat, Dr. Monty Morales

    Product: VenaSeal closure system

    Patient Population: Used in adults with symptomatic venous reflux in the superficial truncal veins for CEAP-6 patients (active ulcer) that will evaluate time to active VLU healing, recurrence, and ulcer-free time.

    VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial – Full Text View – ClinicalTrials.gov


    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 recurrent pericarditis and generate data on the impact and effectiveness of Rilonacept and other available pharmaceutical therapies to treat recurrent pericarditis.

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


    TREO

    Principal Investigator: Dr. Scott Berman

    Sub-Investigators: Dr. Luis Leon, Dr. Joshua Balderman, Dr. Joseph Sabat, Dr. John Pacanowski

    Product: TREO Abdominal Stent-Graft System

    Patient Population: The TREO stent-graft system is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aortoiliac aneurysms.

    Post-Approval Study of the TREO Abdominal Stent-Graft System – Full Text View – ClinicalTrials.gov


    DEFINE GPS

    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


    WAVE

    Principal Investigator: Dr. Scott Berman

    Product: Wrapsody Stent Graft System

    Patient Population: Dialysis patients with stenosis/occlusion in veins in the arm or central access system used for dialysis treatment.

    The Merit WRAPSODY AV Access Efficacy Study (WAVE) – Full Text View – ClinicalTrials.gov


    Clinical Trials in Startup That Will Soon Begin Enrolling

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

    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


    Cardiol: Impact of CardiolRx on Recurrent Pericarditis

    Product: CardiolRx 

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

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


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

    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


    Allay-HF

    Product: ALV1 system

    Patient Population: Patients with heart failure and preserved left ventricle ejection fraction >50% or mid-range left ventricle ejection fraction 40%<EF<50% will be evaluated for treatment via creation of a no-implant interarterial shunt.


    AMGEN-Evolve MI

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

    Patient Population: An evaluation of the effectiveness of early treatment with evolocumab (Repatha) plus routine lipid management vs routine lipid management alone to aggressively lower LDL. It will be administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]). Drug is not metabolized by kidneys or liver.

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


    Lily-GPIJ Trial for Obesity

    Product: Tirzepatide vs placebo

    Patient Population: People with obesity for BMI greater than or equal to 27 with a CVD risk will be randomized to Tirzepatide or placebo to evaluate the effectiveness of Tirzepatide.

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


    CORRAL-AF

    Product: Lambre LAA Closure System

    Patient Population: Patients with non-valvular atrial fibrillation with large and/or irregular shaped appendages who are at increased for stroke and systemic embolism.


    INTEGRA-D

    Product: Optimizer Integra CCM-D system: Cardiac Contractility Modulation and Implantable Cardioverter-Defibrillator

    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 %)


    TMC Trials

    CHAMPION-AF:

    The purpose of this trial is to evaluate the safety and efficacy of the Watchman FLX left atrial appendage closure device within a population of patients with non-valvular atrial fibrillation. The device will be compared to treatment with non-vitamin K antagonist oral anticoagulants (NOACs).

    Principal Investigator: Dr. Thomas Waggoner

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    SAVE:

    The purpose of this trial to reduce the risk of prothesis-patient mismatch rates in patients experiencing stenosis in the aortic valve. The trial will randomize a comparison between Supra-annular valves (Medtronic Evoult Pro) vs. annular valves (Edwards Sapien Ultra) in small annuli.

    Principal Investigator: Dr. Neil Gheewala


    CLASP:

    The purpose of is to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation and in patients with functional mitral regurgitation on guideline directed medical therapy.

    Principal Investigator: Dr. Thomas Waggoner

    Co-Investigator: Dr. Neil Gheewala

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    ENCIRCLE:

    The purpose of this trial is to study the SAPIEN M3 System in symptomatic subjects with mitral regurgitation for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

    Principal Investigator: Dr. Neil Gheewala

    Co-Investigator: Dr. Thomas Waggoner

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    MitraClip REPAIR MR study:

    The purpose of this trail is to compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary mitral regurgitation who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by mitral valve repair surgery.

    Principal Investigator: Dr. Thomas Waggoner

    Co-investigator: Dr. Raj Bose

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    Millipede:

    The purpose of this trial is to evaluate the Millipede Transcatheter Annuloplasty Ring as an option for transcatheter mitral valve repair in patients with moderate to severe mitral regurgitation.

    Principal Investigator: Dr. Thomas Waggoner

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    AMPLATZER PFO Occluder Post Approval Study:

    The purpose of this trial is to prevent recurrent ischemic stroke with the AMPLATZER PFO occluder device.

    Principal Investigator: Dr. Thomas Waggoner

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    NobleStitch El STITCH:

    The purpose of the trial is to collect data on the NobleStitch EL suture mediated closure system to seal a Patent Foramen Ovale (PFO) safely and effectively to reduce the risk of recurrent Ischemic Stroke. The data collected will be compared to PFO closure using the Amplatzer Occluder device.

    Principal Investigator: Dr. Thomas Waggoner

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    TRILUMINATE TriClip Study:

    The objective of this trial is to study the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation.

    Principal Investigator: Dr. Thomas Waggoner

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    Acurate Investigational Device Study:

    The objective of this trial is to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

    Principal Investigator: Dr. Thomas Waggoner

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    Protected TAVR: Sentinel Stroke Protection Randomized Control Study

    The objective of this trial is to reduce the risk of a peri-procedural stroke after a transcatheter aortic valve replacement.

    Principal Investigator: Dr. Thomas Waggoner

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    If you are interested in learning more about any of the trials listed on this page, please fill out the form below and a member of the research team will get back to you in within 24-48 hours.

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