Oregon Heart & Vascular Institute Highlighted Research
HDE: JOMED JOSTENT Coronary Stent Graft
Summary: This device is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts smaller than 2.75 mm in diameter.
Investigators: Stephen Cook, MD; Dennis Gory, MD; Jerold Hawn, MD; Samuel Lau, MD.
SPIRIT III Clinical Trial: A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions
Summary: To determine the safety and efficacy of the XIENCE V Everolimus Eluting Coronary Stent System for the treatment of subjects with a maximum of two de novo native coronary artery lesions.
Investigators: Joseph Chambers, MD; Stephen Cook, MD; Dennis Gory, MD; Jerold Hawn, MD; Samuel Lau, MD; Richard Padgett, MD.
Thoracoscopically Assisted Epicardial Bilateral Pulmonary Vein Isolation Using the Atricure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
Summary: To determine the safety of this operation. To gather data to develop future research trials designed to evaluate how effective this treatment is for atrial fibrillation.
Investigators: James McClelland, MD; David Duke, MD.
Thoracoscopically Assisted Epicardial Bilateral Pulmonary Vein Isolation and Fibrillation (The Wolf Minimaze)
Summary: To collect data for publication on patients undergoing Minimaze procedure. To notify patients that two optional aspects of the standard procedure are routinely performed at Oregon Heart & Vascular Institute at Sacred Heart Medical Center.
Investigators: James McClelland, MD; David Duke, MD.
Asymptomatic Cerebrovascular Accident and Left Atrial Function Following Minimally Invasive Surgery for Atrial Fibrillation Research Protocol
Summary: To identify any neurological or psychological changes and to determine incidence of asymptomatic cerebrovascular accident following minimally invasive surgery for atrial fibrillation, and to evaluate left atrial size and function before and after minimally invasive surgery for atrial fibrillation.
Investigators: James McClelland, MD; David Duke, MD; Raymond Englander, MD; Jon Ekstrom, MD.
A 104-Week, Randomized, Double-Blind, Parallel Group, Multi-Center Phase IIIb Study Comparing the Effects of Treatment with Rosuvastatin 40 mg or Atorvastatin 80 mg on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Patients with Coronary Artery Disease: The SATURN Trial
Summary: To compare the effects of rosuvastatin 40 mg with atorvastatin 80 mg on the percent atheroma volume (PAV) of a coronary artery as measured by intravascular ultrasound imaging following 104 weeks of treatment in patients with coronary artery disease.
Investigators: Stephen Cook, MD; Joseph Chambers, MD: Samuel Lau, MD; Richard Padgett, MD; Dennis Gory, MD; Andrew Fruitkin, MD; Jerold Hawn, MD.
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
Summary: To evaluate clinical outcomes in a cohort of real-world patients receiving the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) during commercial use by various physicians with a range of coronary stenting experience; evaluate patient compliance with adjunctive antiplatelet therapy and major bleeding complications; determine clinical device and procedural success during commercial use; and evaluate patient health status (symptoms, physical function, and quality of life) using the Seattle Angina Questionnaire.
Investigators: Richard Padgett, MD; Joseph Chambers, MD; Dennis Gory, MD; Samuel Lau, MD; Stephen Cook, MD.
The Vest Prevention of Early Sudden Death Trial (VEST) PREDiction of ICD Therapies Study (PREDICTS)
Summary: To test the hypothesis that a non-invasive wearable automatic defibrillator vest will reduce overall mortality in the first 60 days following an MI in participants with left ventricular dysfunction.
Investigators: Ramakota Reddy, MD; Matthew R. Trojan, MD; Samuel Lau, MD; Joseph Chambers, MD; Richard Padgett, MD; Stephen Cook, MD; Jerold Hawn, MD; Dennis Gory, MD; Jay Chappell, MD; James McClelland, MD; Michael Menen, MD; John Gundry, MD; Frances Munkenbeck, MD; Andrew Fruitkin, MD.
Compassionate Use of Temporary Patient Activated Rx (TPARx) Software
Summary: This software system allows delivery of atrial ATP therapy for the treatment of supraventricular tachycardias without regard to a patient’s AV conduction status.
Investigator: James McClelland, MD.
SENTIS Stroke Trial Protocol: Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke
Summary: To demonstrate the safety and efficacy of the NeuroFlo treatment plus medical management relative to medical management alone in improving neurological outcome in ischemic stroke patients.
Investigators: Raymond Englander, MD; Bernard Isuani, MD; Charles McGlade, MD; Matthew Thomson, MD; John Tucker, MD; L. Paul Wilson, MD.
Validation of a Low-Dose One-Day Tc99m Protocol with a High-Efficiency Cardiac Dedicated Gamma Camera for Detection of CAD (SD-DSPECT002)
Summary: To compare an ultra low dose D-SPECT protocol to the standard D-SPECT protocol in order to make the diagnosis of coronary artery disease. The study is designed to produce evidence that a lower dose of imaging agent may be used with the D-SPECT scanner to provide quality imaging at a lower amount of radioactive exposure.
Investigators: Richard Padgett, MD; John Gundry, MD; David Saenger, MD.
Surgery After Previous Failed Catheter Ablation (SAVED)
Summary: To determine the percent success of surgical ablation for atrial fibrillation at 6 and 12 months both on and off of antiarrhythmic drugs following a failed catheter-based ablation for AF, and to record and evaluate all complications associated with the surgical procedure.
Investigators: James McClelland, MD; David Duke, MD.
CYPRESS: A Prospective, Randomized, Multi-Center, Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER Sirolimus-Eluting Coronary Stent (CYPHER Stent)
Summary: To collect data in patients with coronary artery disease who were treated with a CYPHER stent. Data gathered from this study will be combined with other patient data that has been collected in studies utilizing different drug eluting stents to determine how long patients should remain on blood thinning medicines. Aspirin plus one of the two FDA-approved thienopyridine medications (clopidogrel or prasugrel) is commonly called “dual anti-platelet therapy.”
Investigators: Stephen Cook, MD; Richard Padgett, MD; Dennis Gory, MD; Joseph Chambers, MD; Andrew Fruitkin, MD.
The ENTERPRISE Vascular Reconstruction Device and Delivery System – Humanitarian Use Device
Summary: To provide a treatment option for patients with intracranial aneurysms.
Investigator: Erik Hauck, MD.
The Neuroform Microdelivery Stent System – Humanitarian Use Device
Summary: To provide a treatment option for patients who cannot be treated with open brain surgery.
Investigator: Erik Hauck, MD.
The Wingspan Stent System and Gateway PTA Balloon Catheter – Humanitarian Use Device
Summary: To provide a treatment option for patients with intracranial atherosclerotic disease refractory to medical therapy.
Investigator: Erik Hauck, MD.
CRYSTAL AF (CRYptogenic Stroke And underLying AF) Study
Summary: To compare the continuous monitoring by the Reveal XT Insertable Cardiac Monitor to standard-of-care optimal medical treatment in subjects after diagnosis of cryptogenic stroke. This clinical trial will assess the incidence of atrial fibrillation in subjects with a recent cryptogenic stroke or transient ischemic attack, who are at an increased risk of cardiac arrhythmia and to demonstrate the benefit of timely AF detection for patient care.
Investigators: Ramakota Reddy, MD; Raymond Englander, MD.
Compassionate Use Device – EnRhythm Temporary Patient Activated Therapy (TPARx)
Summary: The purpose of the TPARx Software is to inject the TPARx application into the implanted device such that after receipt of a command from a model 2696 INCHECK Patient Assistant, the device will be able to provide atrial ATP therapies for treatment of rhythms with 1:1 conduction.
Investigator: James McClelland, MD.
