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.
Pima Heart + Vascular Partners
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?
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.
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.
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.
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.
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.
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.
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
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%
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.
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.
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.
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.
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
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.
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
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
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
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
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
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
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
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
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
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