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    • Leading-edge Therapies and Protocols

    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 other applicable guidelines.

    For more information, contact us at monica.varela@pimaheartandvascular.com. 

     

    Structural Heart Disease

    AMPLATZER PFO Occluder Post Approval Study

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

    Principal Investigator: Dr. Thomas Waggoner
    Sub Investigators: Drs. Neil Gheewala and William Thomas

    Link to ClinicalTrials.gov

     

    CHAMPION – AF

    The purpose of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

    Principal Investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

    CLASP

    What is the purpose of this study? To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation.

    Principal Investigator: Dr. Thomas Waggoner
    Co-Investigator: Dr. Neil Gheewala

    Link to ClinicalTrials.gov

     

    ENCIRCLE SAPIEN M3 System Study

    The purpose of this study 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

    Link to ClinicalTrials.gov

     

    MitraClip REPAIR MR Study

    The purpose of this study is to compare the clinical outcome of MitraClip™ device versus open surgical repair.

    Principal Investigator Dr. Thomas Waggoner
    Co-Investigator: Dr. Raj Bose

    Link to ClinicalTrials.gov

     

    PROTECTED TAVR Randomized Control Trial

    To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement.

    Principal Investigator: Dr. Thomas Waggoner
    Sub Investigators: Drs. Neil Gheewala and William Thomas

    Link to ClinicalTrials.gov

     

    Restore Ejection Fraction Chart Review

    Aims to replicate real-world evidence and prior clinical investigations to demonstrate the long-term benefits of Protected PCI on LVEF and patient quality of life.

    Principal Investigator: Dr. Thomas Waggoner
    Co-Investigator: Dr. Nader Makki

     

    STITCH NobleStitch EL Study

    The purpose of this study is to collect data on the NobleStitch EL suture mediated closure system to safely and effectively close a Patent Foramen Ovale to reduce the risk of recurrent Ischemic Stroke.

    Principal Investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

    Supra-Annular vs. Annular ValvEs for Small Annuli (≤ 23 mm) (S.A.V.E.) Randomized Control Trial

    The purpose of this study is to reduce risk of prosthesis-patient mismatch rates in patients with a small annuli.

    Principal Investigator: Dr. Neil Gheewala

    Link to ClinicalTrials.gov

     

    TRILUMINATE TriClip Study

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

    Principal Investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

     

    Electrophysiology

    FROZEN AF – IDE Study

    The purpose of the study is to establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for the treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation.

    Principal Investigator: Dr. Darren Peress
    Sub Investigators: Dr. Lionel Faitelson and Michael Arnold NP

    Link to clincaltrials.gov   Boston Scientific’s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation – Full Text View – ClinicalTrials.gov

     

     

    Venous Disease

    Angiodynamics Pathfinder 1 Post Approval Study

    The purpose of the study is to evaluate the use of the Auryron System. The Auryron system is indicated for use in the treatment, including Artherectomy, of intra-inguinal stenosis and occlusions, including in stent restenosis.

    Principal Investigator: Dr. Luis Leon
    Sub Investigator: Dr. John Pakanowski

    Link to Clinicaltrials.gov  

     

    Preliminary Tissue Monitoring During Endovascular (MINI TIME) Feasibility Study

    The purpose of the study is to demonstrate the ability of the Xauron System to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease.

    Principal Investigator: Dr. Luis Leon

    Link to Clinicaltrials.gov   

     

    FlowTriever All-Comer Registry Safety and Hemodynamics (FLASH)

    The purpose of the study is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.

    Principal Investigator: Dr. Joshua Balderman
    Sub Investigators Drs. Scott Berman and Joseph Sabat

    Link to Clinicaltrials.gov 

    The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

    The purpose of the study is to evaluate the VenoValve System, a bioprosthetic venous valve, for the treatment of patients with deep venous valvular insufficiency and the associated complications.

    Principal Investigator: Dr. Scott Berman
    Sub Investigators: Dr. Joshua Balderman, Dr. Luis Leon, Dr. John Pakanowski, Dr. Joseph Sabat, and Jennifer Clark NP

    Link to Clinicaltrials.gov  

     

    Tissue Monitoring During Endovascular Intervention (TIME)

    The purpose of the study is to demonstrate the ability of the Xauron System to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease.

    Principal Investigator: Dr. Luis Leon

    Link to Clinicaltrials.gov  

     

    TREO Post Approval Study

    The purpose of this study is to monitor safety and effectiveness outcomes of the TREO abdominal stent graft system for Infrarenal Abdominal Aortic and Aortic- Iliac Aneurysms.

    Principal Investigator: Dr. Scott Berman
    Sub Investigators: Drs. Joseph Sabat, Joshua Balderman, John Pakanowski, and Luis Leon

    Link to Clinicaltrials.gov  

     

    COVID-19

    Treating COVID-19 with a Bidirectional Oxygenation Valve

    The purpose of this study is to evaluate the if the use of a bidirectional oxygenation mouthpiece with conventional oxygen support enhances respiratory function in any Person Under Investigation for infection by the COVID-19 virus.

    Sub Investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

    Clinical Research at TMC HealthCare

    CARDIOVASCULAR

    AMPLATZER PFO: Occluder Post Approval Study

    What is the purpose of this study? To prevent recurrent ischemic stroke with the AMPLATZER PFO occluder device.

    Principal investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

    CHAMPION – AF

    What is the purpose of this study? To determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

    Principal investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

     

    CLASP

    What is the purpose of this study? To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation.

    Principal investigator: Drs. Thomas Waggoner and Neil Gheewala

    Link to ClinicalTrials.gov

     

    MitraClip REPAIR MR Study

    What is the purpose of this study? To compare the clinical outcome of MitraClip™ device versus open surgical repair.

    Principal investigator: Drs. Thomas Waggoner and Raj Bose

    Link to ClinicalTrials.gov

     

    Protected TAVR: Stroke Protection with Sentinel During Transcatheter Aortic Valve Replacement

    What is the purpose of this study? To reduce the risk of a peri-procedural stroke after a trancather aortic valve replacement.

    Principal investigator: Dr. Thomas Waggoner

    Link to ClinicalTrials.gov

    Of note: TMC is the top global enrolling site for Protected TAVR over six consecutive months.

     

    Supra-Annular vs. Annular ValvEs for Small Annuli (≤ 23 mm) (S.A.V.E.)

    What is the purpose of this study? To reduce risk of prosthesis-patient mismatch rates in patients with a small annuli.

    Principal investigator: Dr. Neil Gheewala

    Link to ClinicalTrials.gov

     

    If you would like more information on how to participate in one of our trials, please fill out the contact form below.