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Creating Knowledge, Saving Lives

Clinical research can be thought of as people-oriented research that tests medications or treatment methods. Clinical research is absolutely vital for any medical institution, because it helps physicians find the newest and best treatments for diseases. As a patient, you can think of clinical research as a team effort between you and your physicians. You get the benefit of having the newest treatments available under the watchful eyes of your physician, and your physician gets your valuable input about the treatment.

Observations from around the world have documented that patients who participate in clinical trials are much better off than those who do not, even if they are in the “no treatment” or placebo group. The attention given by medical personnel involved in the trial, the necessary safeguards integrated into protocols and the pure educational advantage that patients receive translate into overall healthcare benefits for patients.

If you are seeking treatment for vascular disease, we urge you to ask your physician if there is a clinical trial that would be appropriate for you. ProMedica Heart and Vascular Institutes are enrolling patients into clinical trials to find new and better treatments for vascular disease. If you have any questions, you can contact our researchers for more information.

Ongoing Clinical Trials at ProMedica Heart and Vascular Institutes

New Clinical Trial for Deep Vein Thrombosis

Deep Vein Thrombosis (DVT) is a serious medical condition that occurs when a blood clot forms in the deep vein in the body, usually in the leg. Most patients with DVT are treated with blood-thinning drugs (called anticoagulants), which stop the blood clot from growing and prevent other clots from forming. Unfortunately, these drugs do not dissolve the existing clot, which continues to block blood flow and causes permanent damage to the vein. This leads to a condition called the Post-Thrombotic Syndrome, or PTS. PTS can cause chronic pain, heaviness, fatigue, open sores and/or swelling in the affected leg. Up to half of patients who have DVT will develop PTS.

Patients who develop PTS have a reduced quality of life. Fortunately, a new clinical trial called ATTRACT is testing a method of removing blood clots using a specially designed catheter. If clots can be removed early on, then PTS is less likely to develop than if clots are left untreated. In 2008, the Surgeon General issued a National Call to Action to warn the public about the dangers of blood clots. This document recommended that health researchers study methods of dissolving clot to prevent PTS.

The ATTRACT Trial is sponsored by the National Institutes of Health to test a method of treating blood clots that injects a clot-busting drug directly into the clot through a specially designed catheter. Dissolving the clot may relieve DVT symptoms more quickly and prevent vein damage that causes PTS. Jobst Vascular Institute is recruiting patients for the ATTRACT trial. For more information, contact Gina Zoller at 419-291-2087. Download a brochure on the ATTRACT trial

Clinical Trial for Treatment Resistant Hypertension

In the United States, approximately 65 million people suffer from hypertension (high blood pressure), and 20 percent to 30 percent of them have uncontrolled hypertension despite taking medication. Hypertension is called resistant if a person’s blood pressure remains above the goal despite their taking three medications to treat it. As part of a national clinical trial, Jobst Vascular Institute is evaluating a device that has shown promise in treating people with resistant hypertension.

Many factors can contribute to resistant hypertension, including lifestyle factors such as obesity, alcohol use, common over-the-counter analgesics, oral contraceptives and herbal compounds as well as renal disease, sleep apnea and not properly taking medication. Your body’s natural mechanism for controlling blood pressure is known as spontaneous baroreflex sensitivity. Some patients who have treatment-resistant hypertension have impaired spontaneous baroreflex sensitivity. Clinical trials are testing tiny devices that stimulate your body’s natural blood pressure control.

A new fully implantable device designed to electrically stimulate the carotid baroreflex to decrease blood pressure is in Phase II trials. The Rheos® Hypertension Therapy System (CVRx®, Minneapolis, MN) consists of three components: an implantable pulse generator, carotid sinus leads and an external programmer system allowing the physician to set patient-specific dosing. This system uses CVRx-patented Baroreflex Activation TherapyTM (BATTM) technology that is designed to trigger the body’s own natural blood pressure regulation system to control blood pressure. Reports from a multicenter feasibility study suggest that treatment with the Rheos device significantly reduces blood pressure in participants with few adverse outcomes. Though the Rheos Pivotal Trial to evaluate the safety and effectiveness of the device is now closed for enrollment, you can keep an eye out for exciting developments in clinical research by downloading a list of JVI’s currently enrolling clinical trials.

Coronary Artery Stents Clinical Trials

ABSORB: The first ever Bioabsorbable stent VS Xcience used in Cardiac Cath Patients who need PCI.

Principal Investigator: P. Kasi Ramanathan, MD, FACC
Contact the research coordinator: Amy Piotrowski, RN at 419-291-3649

Heart Drug Clinical Trials

MERCK 0859: Anacetrapib along with ongoing statin therapy with or without other lipid modifying medication in patients with hypercholesterolemia or low HDL-C.

Principal Investigator: Paul Berlacher, MD
Contact the research coordinator: Pam Beavers, RN, CCRC at 419-842-3547

Heart Rhythm Clinical Trials

BLOCk-CTI: Examining the Boston Scientific BLAZER ablation catheter for use in typical atrial flutter ablations

Principal Investigator: Mark Richards, MD, PhD, FACC
Contact the research coordinator: Diane Phillip, RN, MSN, CCRC at 419-842-3090

Cardiac Lead Assessment: To examine the leads under safety advisory from St. Jude Medical

Principal Investigator: Mark Richards, MD, PhD, FACC
Contact the research coordinator: Diane Phillip, RN, MSN, CCRC at 419-842-3090

MultiPoint Pacing: A study to evaluate the safety and efficacy of patient treatment with multipoint pacing compared to patient treatment with standard BiV pacing

Principal Investigator: Mark Richards, MD, PhD, FACC
Contact the research coordinator: Diane Phillip, RN, MSN, CCRC at 419-842-3090

INGEVITY: Establish the safety, performance and effectiveness of the INGEVITY Active Fixation and Passive Fixation Pace/Sense Leads

Principal Investigator: Mark Richards, MD, PhD, FACC
Contact the research coordinator: Diane Phillip, RN, MSN, CCRC at 419-842-3090

Siello: Demonstrate the safety and effectiveness of the Biotronik Siello pacing lead.

Principal Investigator: Mark Richards, MD, PhD, FACC
Contact the research coordinator: Amy Barnes, RN at 419-842-3025

LSS of 4SITE: To evaluate, document and report on the appropriate clinical performance, long term reliability, and the functional integrity of the Boston Scientific 4SITE lead/header system that incorporates four conductors into a quadpole DF4 connection that is found in market released ICD and CRT-D devices.

Principal Investigator: Johan Aasbo, DO, FACC
Contact the research coordinator: Amy Barnes, RN at 419-842-3025

Heart Surgery

ABLATE-PASS: The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.

Principal Investigator: Michael Moront, MD
Contact the research coordinator: Tamithy Huber, RN at 419-291-5757

M13-796: This study will evaluate the safety and efficacy of ABT-719 in preventing acute kidney injury in patients undergoing high risk cardiac surgery.

Principal Investigator: Michael Moront, MD
Contact the research coordinator: Tamithy Huber, RN at 419-291-5757


Promise: Compares different, routinely performed heart tests, such as exercise treadmill testing, stress echocardiogram (echo), or cardiac nuclear imaging, and coronary computed tomography angiography (CTA), in identifying heart disease and reducing future heart problems.

Principal Investigator: Mohammed Maaieh, MD, FACC
Contact the research coordinator: Tiffanie Barnhizer, RN, at 419-842-3540

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