Providence Heart and Vascular Institute - eCardioVascular Beat
		
		
		
		Providence Heart and Vascular Institute Clinical Research Department conducts clinical trials involving investigational drugs and devices in interventional cardiology, cardiothoracic surgery, heart failure, rhythm management and vascular surgery/intervention at Providence St. Vincent and Providence Portland medical centers. 
		Our research program consists of a combination of industry-sponsored trials, government-sponsored trials and investigator-initiated trials. Our clinical research coordinators are certified through the Association of Clinical Research Professionals or the Society of Clinical Research Associates. 
		Interventional cardiology  + MORE
		
		
			
				RESPECT
				Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment + MORE 
				
					Enrollment criteria
					Subjects with PFO who have had a "cryptogenic stroke" within the last 270 days. Call for more specific inclusion/exclusion criteria. 
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					AGA Medical Corp. 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
			
				PFO Access Registry 
				Closure Of Patent Foramen Ovale With The Amplatzer® PFO. This Registry allows for PFO closure using the Amplatzer® PFO Occluder device in patients who have had more than one stroke + MORE 
				
					Principal investigator
					Todd Caulfield, M.D. 
					Occluder sponsor
					AGA Medical Corp. 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
			
				SPIRIT PRIME
				A Clinical Evaluation of the XIENCE PRIME™ and XIENCE PRIME™ LL Everolimus Eluting Coronary Stent System + MORE 
				
					Inclusion criteria
					
						- Patients with one or two de novo lesions each in a different epicardial vessel
 
						- Must have TIMI flow of 1 and diameter stenosis =50% and <100%
 
					 
					Exclusion criteria
					
						- MI with enzymes still elevated
 
						- LVEF <30%
 
						- TIA/CVA in past 6 months
 
						- On chronic anticoagulation therapy (Coumadin or heparin)
 
					 
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					Abbott Vascular 
					Contact
					Ellen Muir, clinical research coordinator, 503-216-2110 
				 
			 
			
				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 (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions + MORE 
				
					Enrollment criteria
                    Patients undergoing PCI with either DES or BMS without known contraindication to dual antiplatelet therapy for at least 30 months after enrollment and stent implantation 
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					Harvard Clinical Research Institute (HCRI) 
					Contact
					Maile Barrett, clinical research coordinator, 503-216-2099 
				 
			 
		 
		
		Cardiothoracic surgery  + MORE
		
		
			
				DexCom™ IVBG sensor
				Observational Clinical Study of the Intravenous Blood Glucose System in Hospitalized Adult Elective or Non-Emergent Surgery and Medical/Surgical Intensive Care Unit Patients + MORE 
				
					This is a study of an investigational device called the DexCom™ IVBG sensor. The DexCom™ IVBG sensor is a device that measures blood glucose through a dedicated IV site. The device can measure blood sugar levels every 7 minutes. 
					Principal investigator
					Anthony Furnary, M.D. 
					Sponsor
					Edwards Lifesciences LLC, DexCom Inc. 
					Contact
					Maile Barrett, clinical research coordinator, 503-216-2099 
				 
			 
			
				United States CABG Diabetes Project (USCDP) Feasibility Study
				Enrollment criteria
                Patients with diabetes undergoing CABG surgery randomized to either tight glycemic control for 1 year post-op, or return to their standard glucose management on third post-operative day + MORE 
				
					Principal investigator
					Anthony Furnary, M.D. 
					Sponsor
					Providence Heart and Vascular Institute with funding from Sanofi-Aventis and LifeScan Inc. 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
			
				Numeris™ - AF Tethered Coagulation System with VisiTrax®
				Indicated for the Treatment of Longstanding Persistent Atrial Fibrillation + MORE 
				
					Inclusion criteria
					
						- Patient is between ages of 18 to 80 years old
 
						- Documented longstanding persistent Afib OR non self-terminating Afib
 
						- Patient scheduled for concomitant cardiac procedure
 
					 
					Exclusion criteria
					
						- EF <30%
 
						- History of Afib >10 years
 
						- Left atrial size >6.0
 
					 
					Principal investigator
					E. Charles Douville, M.D. 
					Sponsor
					nContact Surgical Inc. 
					Contact
					Michelle Dixon, C.C.R.C., clinical research coordinator, 503-215-6746 
				 
			 
			
				PROACT Study
				Clinical Trial of the On-X Valve Using Low Dose Anticoagulation + MORE 
				
					Inclusion criteria
					
						- Patient is scheduled to receive ON-X mechanical valve (aortic or mitral)
 
						- Concomitant cardiac surgery IS allowed
 
					 
					Exclusion criteria
					
						- Double (aortic and mitral) valve REPLACEMENT
 
						- Patients with ACTIVE endocarditis
 
						- Previous thromboembolic event within last year
 
					 
					Principal investigator
					E. Charles Douville, M.D. 
					Sponsor
					On-X/MCRI 
					Contact
					Michelle Dixon, C.C.R.C., clinical research coordinator, 503-215-6746 
				 
			 
		 
		
		Heart rhythm  + MORE
		
		
			
				CABANA Trial
				Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation  + MORE 
				
					Inclusion criteria
					
						- Have documented AF episodes >2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week
 
						- Warrant active therapy beyond simple ongoing observation
 
						- Be eligible for catheter ablation and >2 sequential rhythm control and/or >3 rate control drugs
 
						- Be >65 years of age, or <65 years with one or more of the following risk factors for stroke: hypertension, diabetes, congestive heart failure (including systolic or diastolic heart failure), prior stroke or TIA, LA size >5.0cm (or volume index >44cc/m2) or EF<35. Subjects <65 years of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify
 
					 
					Exclusion criteria
					
						- Lone AF in absence of risk factors for stroke in patients <65 years of age
 
						- Patients who in the opinion of managing clinician should not yet receive any therapy for AF
 
						- Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects
 
						- More than 1 week of amiodarone treatment in the past 3 months
 
						- An efficacy failure of full-dose amiodarone treatment >12 weeks duration at any time
 
					 
					Principal investigator
					Blair Halperin, M.D. 
					Sponsor
					National Heart Lung and Blood Institute (NHLBI) 
					Contact
					Maile Barrett, clinical research coordinator, 503-216-2099 
				 
			 
			
				Duo FLAIR
				Clinical Evaluation of Therapy™ Cool Path™ Duo Ablation Catheter System for the Treatment of Typical Atrial Flutter + MORE 
				
					Inclusion criteria
					
						- Presence of typical atrial flutter (cavotricuspid isthmus dependent)
 
						- If subjects receiving antiarrhythmic drug therapy (Class I or Class III AAD) for arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and subsequently had another arrhythmia (i.e. Atrial Fibrillation), then the 3-month AAD criteria will not apply.
 
						- One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months.
 
					 
					Exclusion criteria
					
						- Prior typical atrial flutter ablation treatment
 
						- Atypical flutter or scar flutter (non-isthmus dependent)
 
						- Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NHYA Class III or IV) at the time of enrollment
 
						- A recent MI within 3 months of the intended procedure date
 
						- Permanent coronary sinus pacing lead
 
					 
					Principal investigator
					D. Randolph Jones, M.D. 
					Sponsor
					St. Jude Medical Inc. 
					Contact
					Maile Barrett, clinical research coordinator, 503-216-2099 
				 
			 
		 
		Heart failure  + MORE
		
		
			
				RED-HF
				A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia + MORE 
				
					Inclusion criteria
					
						- Patients with CHF for >3 months, and NYHA class II, III, or IV
 
						- EF <40%
 
						- Hemoglobin must be between: 9.0 g/dL-12.0 g/dL
 
					 
					Exclusion criteria
					
						- B12 or Folate below lower limit of normal
 
						- Tsat is <15%
 
						- CHF is primarily due to valvular disease
 
					 
					Principal investigator
					Ranae Ratkovec, M.D. 
					Sponsor
					Amgen Pharmaceuticals 
					Contact
					Michelle Dixon, C.C.R.C., clinical research coordinator, 503-215-6746 
				 
			 
			
				TOPCAT
				Treatment Of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist + MORE 
				
					Inclusion criteria
					
						- Patients with CHF (new or previous)
 
						- EF >45%
 
						- BNP >100 pg/ml OR hospitalized in last 12 months with CHF
 
					 
					Exclusion criteria
					
						- Serum Potassium >5.0 mmol/L
 
						- MI in past 90 days
 
						- Significant chronic pulmonary disease
 
					 
					Principal investigator
					Ranae Ratkovec, M.D. 
					Sponsor
					National Heart, Lung and Blood Institute, which is part of the NIH 
					Contact
					Michelle Dixon, C.C.R.C., clinical research coordinator, 503-215-6746 
				 
			 
		 
		Vascular intervention  + MORE
		
		
			
				SAPPHIRE WW
				A data collection study using Cordis PRECISE® Nitinol Stent Systems and ANGIOGUARD™ XP/RX Emboli Capture Guidewire for high surgical-risk patients with atherosclerotic disease of the carotid artery(ies) + MORE 
				
					Enrollment criteria
					
						- Symptomatic patients with >50% carotid artery stenosis OR
 
						- Asymptomatic patients with >80% carotid artery stenosis AND
 
						- One or more of the following risk factors:
 
						- 
							
								- Congestive heart failure and/or known severe left ventricular dysfunction LVEF <35%
 
								- Open-heart surgery within six weeks
 
								- Recent MI (>24 hours and <6 weeks)
 
								- Unstable angina
 
								- Synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
 
								- Requirement for simultaneous or staged cardiac valve surgery, peripheral vascular surgery, or AAA repair within 60 days
 
								- Severe pulmonary disease
 
								- Contralateral carotid occlusion
 
								- Contralateral laryngeal palsy
 
								- Post-radiation treatment to the neck
 
								- Previous CEA recurrent stenosis
 
								- High cervical ICA lesions or CCA lesions below the clavicle
 
								- Severe tandem lesions
 
								- Abnormal stress test
 
							 
						 
					 
					Principal investigator
					Brad Evans, M.D. 
					Contact
					Cindy Payne, L.P.N., cardiovascular research coordinator, The Oregon Clinic; 503-963-2946 
				 
			 
			
				CAPTURE-2
				A data collection study of the FDA approved RX ACCULINK™ Carotid Stent System and RX ACCUNET™ Embolic Protection System, in treating narrowed carotid arteries. + MORE 
				
					The CAPTURE-2 Post Market Study is an observational study to collect safety data on patients receiving carotid stents. Patients will be administered a brief neurologic exam (NIH Stroke Scale) before their carotid procedure, 24-hour post-procedure, and at a 30-day office visit. 
					Enrollment criteria
					
						- Symptomatic patients with >50% carotid artery stenosis OR
 
						- Asymptomatic patients with >80% carotid artery stenosis
 
					 
					Principal investigator
					Brad Evans, M.D. 
					Contact
					Cindy Payne, L.P.N., cardiovascular research coordinator, The Oregon Clinic; 503-963-2946 
				 
			 
		 
		Peripheral vascular  + MORE
		
		
			
				PROVIDE
				Post-Market Observation Study of Intra-renal Drug Delivery + MORE 
				
					Principal investigator
					Naveen Sachdev, M.D. 
					Sponsor
					AngioDynamics 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
			Neurovascular intervention
			
				CORDIS ENTERPRISE™
				Use of the Vascular Reconstruction Device and Delivery System + MORE 
				
					Investigators
					John Roll, M.D., Todd Kuether, M.D. 
					Device sponsor/manufacturer
					Cordis Neurovascular Inc. 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
		 
		Stem Cell/OMLC  + MORE
		
		
			
				Research Study on Cardiac Stem Cells for Myocardial Repair
				+ MORE 
				
					Principal investigator
					Kenton Gregory, M.D. 
					Sponsor
					Oregon Medical Laser Center 
					Contact
					Eric Johnson, C.C.R.C., clinical research supervisor, 503-216-2075 
				 
			 
		 
			
		In follow-up  + MORE
		
		
			
				Interventional cardiology
				Harmonizing Outcomes with RevascularIZatiON and Stents "HORIZONS" Acute MI Study + MORE 
				
					Principal investigator
					Brad Evans, M.D. 
					Sponsor
					Cardiovascular Research Foundation 
				 
			 
			
				TAXUS PERSEUS
				A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions + MORE 
				
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					Boston Scientific Corp. 
				 
			 
			
				PLATINUM
				A Prospective, Randomized, Multi-Center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS™ Element™) for the Treatment of Up to Two de novo Coronary Artery Lesions + MORE 
				
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					Boston Scientific Corp. 
				 
			 
			
				SPIRIT III
				A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent (EECS) System in the Treatment of Subjects with de novo Native Coronary Artery Lesions + MORE 
				
					Principal investigator 
					Todd Caulfield, M.D. 
					Sponsor
					Guidant Corp./Abbott Vascular Inc. 
				 
			 
			
				SPIRIT IV
				A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions + MORE 
				
					Principal investigator
					Todd Caulfield, M.D. 
					Sponsor
					Abbott Vascular Inc. 
				 
			 
		 
	
		Cardiothoracic surgery  + MORE
		
		
			
				Artificial Valve Endocarditis Reduction Trial (AVERT)
				A Prospective Randomized Trial to Determine the Effects of Silzone Coating on the Incidence of Prosthetic Valve Endocarditis (also conducted at PPMC) + MORE 
				
					Principal investigators
					Jeffrey Swanson, M.D., E. Charles Douville, M.D. 
					Sponsor
					St. Jude Medical S.C., Inc. 
				 
			 
			
				Mitroflow Synergy PC Valve Study
				G020247/S001 CarboMedics/Sorin + MORE 
				
					Principal investigator
					Jeffrey Swanson, M.D. 
				 
			 
		 
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