Providence Heart and Vascular Clinical Research

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Researchers at Providence Heart and Vascular Institute are studying the most advanced techniques, tools and technology to treat people with a range of cardiovascular conditions. Here, patients can access therapies available only through clinical research studies.


ABSORB III

ABSORB III Randomized Controlled Study – Clinical Evaluation of the Absorb Bioresorbable Vascular Scaffold (BVS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions

This is a study of an investigational (not approved by the U.S. Food and Drug Administration) device for the treatment of coronary artery disease (CAD) called the Absorb Bioresorbable Vascular Scaffold (BVS) System (the “Absorb BVS”).

Angioplasty, with or without the placement of a stent, is a standard treatment for CAD. During an angioplasty, an inflatable balloon attached to the end of a thin flexible tube (called a catheter) is put into a vein in the groin and guided to the heart's narrowed artery. There the balloon is temporarily inflated. The balloon pushes the blockage (also called a lesion) against the artery wall and opens up the heart artery, improving blood flow to the heart. It is often followed by the placement of a small metal mesh tube, called a stent, in the narrowed area of the artery to help keep the artery open. The stent may be coated with a medication that decreases the chance of the artery narrowing again (restenosis). This type of stent is known as a “drug-eluting” stent. A stent remains in the heart permanently.

The Absorb BVS is designed to open the blockage similar to a traditional metallic stent but then the device dissolves over time. The purpose of this study is to see how effective and safe the Absorb BVS is for treating patients with CAD. The Absorb BVS will be compared to one of the following standard drug-eluting stents: the XIENCE V®, XIENCE PRIME®, XIENCE PRIME® LL, or XIENCE Xpedition® Everolimus Eluting Coronary Stent System (together called the XIENCE stent).

Some of the general inclusion criteria:

  1. Patient must be at least 18 years of age.
  2. Patient or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  3. Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and

Principal investigator: Ethan Korngold, M.D.
Sponsor: Abbott
Contact: Sarah P. Grant, clinical research coordinator, 503-216-7370

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ISCHEMIA

International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

The purpose of this study is to learn more about how to help people who have narrowed heart arteries due to the buildup of cholesterol. When a heart artery narrows some part of the heart may not receive enough blood to work normally. This is a multicenter randomized controlled trial with a target enrollment of 8,000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT. There are no experimental tests, procedures, or medicines used in either group.

Some of the general inclusion criteria:

  1. At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10 % myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (≥12% myocardium).
  2. Participant is able to understand and to give written informed consent.
  3. Age ≥ 21 years.

Principal investigator: Charles R. Cannan, M.D.
Sponsor: National Heart, Lung and Blood Institute (NHLBI)
Contact: Lindsay Severson, CCRC, clinical research coordinator, 503-962-1026

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CABANA

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial

The purpose of this study (CABANA) is to compare catheter ablation to drug therapy for atrial fibrillation (an abnormal heart rhythm that starts in the top chambers of the heart and causes a fast heartbeat). This study will help decide which treatment approach is better or if one or the other therapy is preferred. This study will see if either drug therapy or catheter ablation is more effective at controlling the heart rate and rhythm, or helps prevent problems that can be caused by atrial fibrillation (AF) (such as strokes or heart attacks). The CABANA study will also compare the cost of care for the two treatment approaches and see the effect these therapies have on quality of life.

Some of the general inclusion criteria:

  1. Patient must be at least 18 years of age and < 65 years of age.
  2. Over the preceding six months have:
    1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
    2. Electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
    3. Electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
  3. Warrant active therapy (within the past 3 months) beyond simple ongoing observation.
  4. Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs.

Principal investigator: Blair Halperin, M.D.
Sponsor: National Heart, Lung and Blood Institute/Mayo Clinic
Contact: Heather Aiona, CCRC, clinical research coordinator, 503-216-2099

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RIATTA 2

St. Jude Medical Cardiac Lead Assessment Study

The purpose of this study is to find out how many people with St. Jude Medical Riata/Riata ST, Quicksite/QuickFlex, or Durata defibrillation leads have internal wires that are visible outside of the silicone insulation (externalized conductors), or other problems that can be seen. Another goal is to see how many patients with externalized conductors experience malfunction or side effects because of the exposed internal wires.

Some of the general inclusion criteria:

  1. ≥18 years of age.
  2. Have one of the above devices.
  3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in the study.

Principal investigator: Randy Jones, M.D.
Sponsor: St. Jude Medical
Contact: Kelly Herwig, clinical research coordinator, 503-216-2104

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Medtronic Product Surveillance Registry (formerly known as Product Performance Platform)

Medtronic Product Surveillance Registry (PPP-AFP)

The main purpose of the System Longevity Study is to evaluate long-term performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities. This study is part of the Product Performance Platform (PPP).

Some of the general inclusion criteria:

  1. Able to understand and provide written informed consent.
  2. AND one of the following must also apply:

  3. Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application.
  4. Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data to SLS.
  5. Subjects implanted with Medtronic CapSure Epi Leads (4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.

Principal investigator: Ronald Peterson, M.D.
Sponsor: Medtronic
Contact: Lindsay Severson, CCRC, clinical research coordinator, 503-962-1026

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Enrolling structural studies:

COAPT

Cardiovascular Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT). A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the treatment of moderate-to-severe or severe functional mitral regurgitation in symptomatic heart failure subjects who are not candidates for mitral valve surgery.

The purpose of this study is to evaluate the safety and effectiveness of the MitraClip system in treating patients with moderate-to-severe or severe functional mitral regurgitation and symptomatic heart failure who are not candidates for mitral valve surgery.

The MitraClip System consists of two main parts: a delivery catheter (a hollow, flexible tube that is inserted into a vein), and a clip which is implanted into your heart. The MitraClip device is made of metal and is covered with polyester fabric. It is different from standard treatment in that it is being tested to see if it can safely and effectively repair the mitral valve without surgery. If you qualify and you choose to take part, the MitraClip will be put into your body through a vein in your groin (where the thigh meets your hip) and guided through your vein to your heart. Once there, it is placed in the middle of your mitral valve leaflets in a way that allows its arms to attach to the bottom of the leaflets. Once they're attached, the clip is closed to securely hold the leaflets together at the point where the clip closes.

Some of the general inclusion criteria:

  1. Age 18 years or older.
  2. This study is very specific in its inclusion criteria for patients with mitral regurgitation so please contact the clinical research coordinator for more information.

Principal Investigator: Ethan Korngold, M.D.
Sponsors: Abbott
Contacts: Kelly Herwig, CRC, clinical research coordinator, 503-216-2104, or Michelle Dixon, CCRC, clinical research coordinator, 503-215-6746

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PARTNER

The Safety and Effectiveness of the Sapien XT Transcatheter Heart Valve with NovaFlex and Ascendra delivery systems in Intermediate and High Risk for Aortic Valve Surgery and Patients Who Cannot Undergo Surgery and the Sapein 3 Transcatheter Heart Valve with Associated Delivery Systems in Intermediate and High Risk or Inoperable Patients with Severe Symptomatic Aortic Stenosis

The purpose of this study is to see how effective and safe the SAPIEN XT Transcatheter Heart Valve and the delivery systems: NovaFlex (transfemoral access) and Ascendra (transapical and transaortic access) might be in treating aortic valve stenosis (narrowing of the aortic valve resulting in reduced blood flow). These delivery systems are also considered investigational in this study.

Principal investigators: Robert Hodson, M.D., and Jeff Swanson, M.D.
Contacts: Angela Redd, CCRC, clinical research coordinator, 503-216-2170, or Katie Orwoll, clinical research coordinator, 503-216-7162

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Enrolling peripheral studies:

ILLUMENATE

Prospective, Randomized, Multi-Center, Single-Blind Study for the Treatment of Subjects Presenting with De Novo Occluded/Stenotic or Re-occluded/ Restenotic Lesions of the Superficial Femoral or Popliteal Arteries using a Paclitaxel-Coated or Bare Percutaneous Transluminal Angioplasty Balloon Catheter

This is a study of an investigational device called the CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel Coated Balloon). This device is considered investigational because it is not approved by the Food and Drug Administration (FDA) for the treatment of narrowed leg vessels.

Standard treatment for blocked or narrowed blood vessels includes balloon angioplasty. During balloon angioplasty the doctor threads a hollow flexible tube (called a catheter) to the site of the blockage in the blood vessel. The tube has a tiny balloon on the end. When the tube is in place, the doctor inflates the balloon to push the blockage outward against the wall of the blood vessel. This widens the vessel and restores blood flow.

The CVI Paclitaxel Coated Balloon is the same shape and size as other balloon catheters. It is different because the surface of the balloon is coated with a drug called paclitaxel. Paclitaxel prevents the growth of cells. It is approved by the FDA to treat certain types of cancer, and to coat stents (small metal mesh-like tubes that are permanently placed inside a blood vessel to help keep it open) for heart, abdomen and leg vessels.

The purpose of this study is to see how safe the CVI Paclitaxel Coated Balloon is, and how effective it is in treating patients with blocked or narrowed blood vessels in the leg.

Some of the general inclusion criteria:

  1. Has clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
  2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2-3 subjects should be entered into the study if conservative treatment or medicinal therapy have been unsuccessful.
  3. Is at least 18 years of age.

Principal investigator: Ethan Korngold, M.D.
Sponsor: Covidien
Contact: Sarah P. Grant, clinical research coordinator, 503-216-7370

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LUTONIX

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries Lutonix BTK Trial)

This is a study of an investigational (not approved by the U.S. Food and Drug Administration) device for the treatment of narrowed blood vessels below the knee, called the Lutonix Drug Coated Balloon Catheter.

Standard treatment for blocked or narrowed blood vessels includes balloon angioplasty. During balloon angioplasty the doctor threads a hollow flexible tube (called a catheter) to the site of the blockage in your blood vessel. The tube has a tiny balloon on the end. When the tube is in place, the doctor inflates the balloon to push the blockage outward against the wall of the blood vessel. This widens the vessel and restores blood flow.

The Lutonix Drug Coated Balloon (DCB) Catheter is different from other balloon catheters in that the surface of the balloon is coated with paclitaxel. Paclitaxel is a drug that prevents the growth of cells. It is approved by the FDA to treat certain types of cancer, and to coat stents (small metal mesh-like tubes that are permanently placed inside a blood vessel to help keep the blood vessel open) for heart and leg vessels. Researchers hope that the paclitaxel coating on the Lutonix DCB will reduce the likelihood that your blood vessel will re-narrow in the future.

The purpose of this study is to see how safe the Lutonix DCB Catheter is and how effective it is in treating patients with blocked or narrowed blood vessels below the knee.

Patients who take part in this study will be randomly assigned (by chance, like the flip of a coin), to receive treatment with either the Lutonix DCB or a standard balloon catheter. Two thirds of patients who take part will be treated with the Lutonix DCB catheter; the other third will be treated with a standard balloon catheter.

Some of the general inclusion criteria:

  1. ≥18 years of age.
  2. Rutherford Clinical Category 4-5.
  3. Significant stenosis (≥70%).
  4. Ability to understand and sign informed consent.

Principal investigator: Ethan Korngold, M.D.
Sponsor: Lutonix Inc.
Contact: Sarah P. Grant, clinical research coordinator, 503-216-7370

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TIGRIS

Evaluation of the GORE TIGRIS Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries

The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral artery disease (PAD).

Some of the general inclusion criteria:

  1. ≥21 years of age.
  2. Rutherford Clinical Category 2-4.
  3. Ability to understand and sign informed consent.

Principal investigator: Ethan Korngold, M.D.
Sponsor: W.L. Gore and Associates
Contact: Ellen Muir, CRC, clinical research coordinator, 503-216-2110

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Enrolling heart failure studies:

Heart Failure and Telemedicine

Protocol for Demonstration Project Using Technology to Improve Health Outcomes for Hospitalized Patients with Heart Failure Discharged to Skilled Nursing Homes

The purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a skilled nursing facility. Telemedicine uses electronic communications to make patient/doctor visits possible from a distance.

Principal investigator: Jacob Abraham, M.D.
Grant funded
Contact: Suzanne Webber, NP, 503-216-2500

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Active but not enrolling:

LAPTOP

Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study (LAPTOP-HF)

The purpose of this clinical study is to evaluate the safety and clinical effectiveness of the use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure (HF). The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group).

Some of the general inclusion criteria:

Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction or heart failure for at least 6 months.

  1. Is at least 18 years of age.
  2. Able to understand and sign informed consent.
  3. Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy.

Principal investigator: Jacob Abraham, M.D.
Sponsor: St Jude Medical
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AVERT

A prospective randomized trial to determine the effects of Silzone coating on the incidence of prosthetic valve endocarditis

Sponsor: St. Jude Medical
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BICOR

Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves

Sponsor: St Jude Medical
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Magna Ease

Carpentier-Edwards Perimount Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX

Sponsor: Edwards Lifesciences
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Mitroflow Registry

Long Term Follow-Up and Hemodynamic Evaluation of the Mitroflow Aortic Pericardial Heart Valve

Sponsor: Carbomedics Inc.
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CANOPY

Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Sponsor: Abbott
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Chocolate Registry

The Chocolate Balloon Angioplasty Registry

Sponsor: TriReme Medical Inc.
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DAPT

A prospective, multicenter, 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.

Sponsor: Harvard Clinical Research Institute
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Evolve II

A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) for the Treatment of Atherosclerotic Lesion(s)

Sponsor: Boston Scientific
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IMPROVE IT

A multicenter, double-blind, randomized study to establish the clinical benefit and safety to establish the clinical benefit and safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin monotherapy in high-risk subjects presenting with acute coronary syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT)

Sponsor: Schering-Plough Research Institute
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MOMENTUM

Absolute Pro® MOMENTUM Trial to determine the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery and/or native proximal popliteal artery.

Sponsor: Abbott
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PEGASUS

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

Sponsor: AstraZeneca
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PLATINUM

A prospective, randomized, multicenter trial to assess an Everolimus-Eluting coronary stent system (PROMUS Element) for the treatment of up to two De Novo coronary artery lesions

Sponsor: Boston Scientific
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PROACT

Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation – AVR or MVR patients

Sponsor: Medical Carbon Research Institute
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QUICKFLEX

QuickFlex Model 1258T left heart pacing lead post-approval study

Sponsor: St Jude Medical
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RESPECT

Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

Sponsor: AGA Medical LLC
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