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COVID-19 Announcement

Clinical Trials

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  • 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.


    PH&V Trials: Investigators

    Trials that are currently enrolling:

    FLASH:

    Principal Investigator: Dr. Joshua Balderman

    Sub-investigators: Dr. Scott Berman, Dr. Joseph Sabat, Dr. Bernardo Mendoza

    Product: FlowTriever Retrieval/Aspiration System

    Patient Population: The FlowTriever system is used for the removal of emboli from pulmonary arteries in the treatment of acute pulmonary embolism.

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    TREO:

    Principal Investigator: Dr. Scott Berman

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

    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 aortoliliac aneurysms.

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    Resonance:

    Principal Investigator: Dr. Thomas Waggoner

    Sub investigator: Dr. Greg Koshkarian and Dr. Ajay Tuli

    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.

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    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.

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    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 that will evaluate time to active VLU healing, recurrence, and ulcer-free time.

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    SAVVE:

    Principal Investigator: Dr. Scott Berman

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

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    –

    Other open trials:

    Frozen-AF:

    Principal Investigator: Dr. Darren Peress

    Sub-investigator: Dr. Lionel Faitelson

    Product: Boston Scientific Cardiac Cryoablation System

    Patient Population: Intended for treatment for patients that experience symptomatic, drug refractory, recurrent, paroxysmal AFib.

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    Pathfinder:

    Principal Investigator: Dr. Luis Leon

    Sub-investigator: Dr. John Pacanowski

    Product: Auryon Atherectomy System 

    Patient Population: The Auryon system will be used to treat Rutherford class 2-5 PAD subjects with infrainguinal stenoses and occlusions, including in-stent restenosis lesions.

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    *DEFINE GPS*:

    Principal Investigator: Dr. Thomas Waggoner

    Sub-investigators: Dr. Rajen Desai, Dr. Mukesh Gopalakrishnan, Dr. Ajay Tuli, Dr. Nader Makki, Dr. James Myer

    Product: iFR Co-registration vs. SyncVision co-registration system

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

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    *AIM Higher*:

    Principal Investigator: Dr. Darren Peress

    Sub-investigator: Dr. Lionel Faitelson

    Product: Optimizer Smart Mini System

    Patient Population: An evaluation of cardiac contractility modulation therapy in patients with symptomatic heart failure with an LVEF of>40% and <60%.

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    *SAFE MCS*:

    Principal Investigator: Dr. Thomas Waggoner

    Product: Saranas Early Bird bleeding monitoring system- 6F and 8F

    Patient Population: Patients undergoing complex high-risk PCI with mechanical circulatory support via Impella and transfemoral arterial approach.

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    *US Post-Market Surveillance Study of the Surfacer System*

    Principal Investigator: Dr. Scott Berman

    Product: Surfacer® Inside-Out® Access Catheter System

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

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

    Product: Inclisiran vs placebo*

    Principal Investigator: Dr. Ajay Tuli

    Sub-investigators: Dr. Thomas Waggoner and Dr. Greg Koshkarian

    Patient population: Patients with established atherosclerotic cardiovascular disease will be given inclisiran (reduces low-density lipoprotein cholesterol) or a placebo to evaluate the benefits of inclisiran on major adverse cardiovascular events.

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    *Boston Scientific-PolarFit-extension to PolarRX*

    Principal investigator: Dr. Darren Peress

    Product: PolarRX cardiac cryoablation system

    Patient population: Patients currently in paroxysmal AFib.

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    *indicates trial will be enrolling soon*


    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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