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.
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.
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%
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.
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.
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.
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
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.
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.
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
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