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Clinical Research

Studies and trials currently underway in the PeaceHealth Sacred Heart Medical Center Research Department

(Updated March 1, 2014)

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

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia)

Summary: A prospective multi-center, nonrandomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.

Investigator: Ramakota Reddy, MD

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

The Penumbra System in the Treatment of Acute Stroke (THERAPY)
Summary: The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA) in patients with acute ischemic stroke from large vessel occlusion in the brain.

Investigators: Erik Hauck, MD, PhD; Jorge Eller, 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, PhD

The ABSORB III Randomized Controlled Trial (RCT)

Summary: A clinical evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the treatment of subjects with de novo native coronary artery lesions.

Investigators: Dennis Gory, MD; Richard Padgett, MD; Stephen Cook, MD; Sudeshna Banerjee, MD

GLORIA-AF Registry Program (Phase II/III)

Summary: In this part of the Registry Program, patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events.

Investigator: Fran Munkenbeck, MD

GLobal Assessment of plaque reGression with a PCSK9 antibOdy as measured by intraVascular ultrasound (GLAGOV)

Summary: This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.

Investigators: Richard Padgett, MD; Stephen Cook, MD; Sudeshna Banerjee, 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, PhD

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 patient's AV conduction status.

Investigator: James McClelland, MD

OPEN Chronic Total Occlusion (OPEN-CTO)

Summary: This is an observational registry. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.

Investigator: Stephen Cook, 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 a 1:1 conduction.

Investigator: James McClelland, MD 

Studies Under Consideration

A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Summary: This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for three months after randomization.

Investigators: Erik Hauck, MD, PhD; Jorge Eller, MD 

Management of Myocardial Injury After Noncardiac Surgery Trial (MANAGE)

Summary: Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.

Investigator: Arturo Salazar, MD 

Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF

Summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin​, when added to standard therapy, in acute heart failure (AHF) patients.

Investigator: Stephen Cook, MD 

Contact Us

Please let us know if you have interest in any particular areas and we will seek out those trials. Please call with questions or concerns. Becky, RN, 541-222-1947 or cell 541-510-9308.

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