Healthy Living Tips

Clinical Research

New Treatments. Therapies and Technologies
 

Heart & Vascular Center of Arizona Research Center's mission is to provide patients access to the most advanced clinical practices and technologies.  Heart & Vascular Center's innovative, multi-disciplinary approach results in new treatments, therapies and technologies that provide patients with the most effective care possible.

Community-based clinical research trials are vital to the comprehensive heart care available at Heart & Vascular Center of Arizona.  The clinical trials currently open are listed below by disease type.  

For additional information visit www.clinicaltrials.gov.  ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals. 

Atrial Fibrillation

ARISTOTLE
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

The purpose of this study is to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Sub-Investigator: Nathan Laufer, MD
Sponsor: BMS-Pfizer-PPD
Enrollment Status: Ongoing, closed to enrollment

Carotid Artery Disease
 

SAPPHIRE WW
Stenting and Angioplasty with Protection in Patients At High-Risk for Endarterectomy

The purpose of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease using the Cordis PRECISE® Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire. Both of these devices are approved by the FDA.
 
Principal Investigator: Nathan Laufer, MD
Sponsor: Cordis
Enrollment Status: Open
 
CHOICE
CHOICE is a worldwide post-market registry that will include both of Abbott’s carotid artery stenting and embolic protection systems.
CHOICE may include as many as 5,000 patients and will be conducted at several hundred clinical sites in the United States and Europe. Primary endpoints for CHOICE are stroke, death and MI at 30 days. The study will also help gather additional and more extensive clinical data to broaden patient access to carotid stenting procedures. Data from CHOICE will also provide a deeper and broader understanding of carotid stenting in international clinical settings.
 
Principal Investigator: Ashish Pershad, MD
Sponsor: Abbott Vascular
Enrollment Status: Open

Cardiac Catheterization

PROTECT II
A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI
The purpose of the study is to prove the IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
 
Principal Investigator: Ashish Pershad, MD
Sponsor: Abiomed Inc.
Enrollment Status: Ongoing

The DAPT Study  
A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.  

Principal Investigator: Nathan Laufer, MD
Sub Investigator:  Ashish Pershad, MD, Adam Brodsky, MD, Parminder Singh, MD
Sponsor: Harvard Clinical Research Institute
Enrollment Status: Open

Congestive Heart Failure

PARADIGM-HF
“A multicenter, randomized, double-blind, parallel group active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction.”

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF< 40%).
 
Principal Investigator: Nathan Laufer, MD
Sponsor: Novartis
Enrollment Status: Open

Diabetes Mellitus and Acute Coronary Syndrome

The EXAMINE TRIAL
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome
The purpose of this study is to demonstrate that no excess risk of major adverse cardiac events (MACE) exists following treatment with study drug compared with placebo when given in combination with Standard of Care in subjects with Type II Diabetes and Acute Coronary Syndrome. For the purposes of this study, the primary MACE composite is defined as: CV death; nonfatal MI; and nonfatal stroke.
 
Principal Investigator: Nathan Laufer, MD
Sponsor: Takeda Global Research & Development Center, Inc.
Enrollment Status: Open

 

Electrophysiology

Shock-Less Study
The purpose of this quality improvement study is to allow Medtronic and participating investigators to better address the quality of care patients receive by assessing the utilization of shock reduction programming features. 

Principal Investigator: Ashish Sadhu, MD
Sponsor: Medtronic, Inc.
Enrollment Status: Open
 
 
BRADYCARE
Advanced BRADYCARrdia Device Feature Utilization and Clinical OutcomeEs
The purpose of this study is to evaluate the usage of advanced features and diagnostics in patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. 
 
Principal Investigator: Ashish Sadhu, MD
Sponsor: St. Jude Medical
Enrollment Status: Closed 
 
RATE Registry – Registry of Atrial Tachyarrhythmia/Atrial Fibrillation Episodes in the Cardiac Rhythm Management Device Population
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select St. Jude Medical devices.
 
Principal Investigators: Ashish Sadhu, MD, Nathan Laufer, MD
Sponsor: St. Jude Medical
Enrollment Status: Open
 
Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter (CONTACT AFL)
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size.

Co-Investigators: Ashish Sadhu, MD 
Sponsor:  St. Jude Medical
Enrollment Status:   Coming Soon

 

Peripheral Vascular

SUPERB Study
The overall goal of the study is to evaluate the safety and efficacy of the IDEV SUPERA® Nitinol Stent System in treating patients with obstructive superficial femoral artery disease – commonly known as superficial femoral artery (SFA). The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of PTA alone.

 Principal Investigators: Ashish Pershad, MD, Adam Brodsky, MD
Sponsor:  IDEV
Enrollment Status:  Open

 

Post MI - Post ACS

AngelMed for Early Recognition and Treatment of STEMI (ALERTS)
A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.

The largest proportion of the total pre-hospital delay is the interval between the onset of symptoms and the decision to seek medical treatment. Finnegan et al. described that the reasons for delay in seeking medical evaluation generally stem from patient misconceptions about symptom experience, expectations, and attribution. In many cases, patients expect the type of heart attack that they often see in movies or on television: the kind of crushing chest pain that drops a person to the ground. The reality is that many heart attacks are much "quieter," causing only mild chest pain or discomfort or other symptoms such as shortness of breath or diaphoresis.

If patients would take action during the first hour following symptom onset, many lives and significant cost could be saved. It is technically possible to monitor EKGs and detect an acute infarction, even if the patient is unaware that he or she is experiencing a heart attack. However, currently available systems have limitations in the home environment. Twelve lead EKG systems require a clinically trained individual to place them. Holter monitors suffer from limitations in the ability to detect ST deviation due to low compliance and are limited in practice to 24 to 72 hours of monitoring. Systems using surface leads are all subject to noise and other artifacts from patient movement and body orientation, particularly if the patient is ambulatory.

A potentially ideal solution is to implant a device that measures heart signals from inside the heart and will alert the patient when it detects electrogram characteristics set by the physician as worthy of medical evaluation.

Principal

Investigator: Ashish Pershad, MD
Sponsor:  Angel Medical Systems, Inc.
Enrollment Status:   Open