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Research Trials in the Center for Heart Rhythm Disorders

Researchers in Northwestern Memorial Hospital's Center for Heart Rhythm Disorders at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating heart rhythm disorders.

Clinical research trials search for new and better ways to understand and treat disease.  Participating in a clinical research trial is an informative learning experience for the volunteer.  Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge.  The following clinical research trial(s), specific to heart rhythm disorders, are currently recruiting volunteers:

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP-AF PAS)

Principal Investigator:
Bradley Knight, MD (profile opens in new window)
IRB Project Number:
STU00063507
Description of Research Trial:

The STOP-AF PAS trial is recruiting patients who are going to have or who have recently had a cryoablation procedure for treatment of abnormal atrial contraction.

The purpose of this study is to collect information over time regarding the effectiveness and safety of the Arctic Front® Cardiac Cryoablation Catheter System, including the Freezor® MAX Cardiac cryoablation catheter (“Study Device”). The Study Device is approved by the Food & Drug Administration (FDA) and is commercially available. This study is required by the FDA in the United States to monitor performance of the Study Device.

About 400 subjects will be in this study in the United States and Canada.  We hope to enroll up to 15 subjects here at Northwestern.  Participation in this study may last for approximately 60 months (5 years).

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

Acute Multi-Signal Data Collection Study

Principal Investigator:
Bradley Knight, MD (profile opens in new window)
IRB Project Number:
STU00070964
Description of Research Trial:

The AMSD study is looking for patients who will be having an electrophysiology (EP) study, a heart ablation procedure, an ICD implant, or an ICD change-out as part of their routine medical care.

The purpose of this study is to record and collect heartbeat data from a patient’s implanted ICD device during a routine heart procedure.  The information collected for this study may help in the development of new features and settings for future ICD devices.

No special visits will be required just for this study.  The data will be collected during a heart procedure that patients will be having as part of their routine care.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

TACTIC-AF (Tailored Anticoagulation for Non-Continuous Atrial Fibrillation) Pilot Study

Principal Investigator:
Rod Passman, MD (profile opens in new window)
IRB Project Number:
STU00066589
Description of Research Trial:

TACTIC-AF is recruiting patients who have been diagnosed with Atrial Fibrillation and currently have a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device implanted.

The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of AF based on information from a pacemaker or ICD.  Anticoagulation medication prevents the formation of blood clots in the body. Examples of this kind of medication are Dabigatran and Pradaxa.

This study will enroll up to 200 patients at 20 centers located in the United States. The study may last up to 2 years depending on the rate of enrollment. Your participation will be completed at 1 year.
Research Trial Contact Information:

For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org

Analyze ST: ST Monitoring to Detect ACS Events in ICD Patients Study

Principal Investigator:
Susan Kim, MD (profile opens in new window)
IRB Project Number:
STU00056406
Description of Research Trial:

The Analyze-ST study is recruiting patients who will be having an implant or replacement of an Implantable Cardioverter Defibrillator (ICD). 

An ICD is an electronic, battery-powered medical device that is implanted in the chest area to continually monitor the heart and deliver appropriate therapy when an abnormal heart rhythm is detected.  It is designed to help the heart beat regularly.  If the heart is beating too fast, the ICD will deliver electrical pulses or shocks to the heart muscle to help the heart beat regularly again.  Also, if the heart beats too slowly, electrical impulses will be delivered to the heart muscle to help the heart beat normally again.

Participants in this study will receive an ICD that has the capabilities described above but also has a new feature (ST Monitoring Feature) that has yet to be proven or approved.  This new and investigational feature being studied is designed to record heart rhythm tracing when the heart is not getting enough oxygen due to a blockage in a heart blood vessel.  In addition, it can alert the participant or the participant’s doctor of these changes when they happen.

The purpose of this study is to test the accuracy of the ST Monitoring Feature, and determine if the information provided by the ST Monitoring Feature will help doctors manage the care of patients with abnormal heart rhythms.

A total of 5,228 patients will be enrolled in the Analyze ST IDE study and up to 200 US investigational sites will conduct the study.  We expect to enroll up to 10 subjects at Northwestern.  The study is expected to take about 48 months depending on how fast patients are signed up to participate.  Individual participation in the study will be at least 12 months and may be extended up to 6 years.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact Maggie McCarthy at (312) 926-9874 or e-mail mmccart3@nmh.org

ABLATE Post-Approval Study: AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Principal Investigator:
Patrick McCarthy, MD (profile opens in new window)
IRB Project Number:
STU00067622
Description of Research Trial:

The ABLATE Post-Approval Study is looking for patients who have been diagnosed with a non-paroxysmal (does not resolve on its own within 7 days) form atrial fibrillation (“AF”).  AF is an irregular heartbeat, which may cause symptoms such as pounding sensations in your chest, dizziness, fatigue, chest pain and/or shortness of breath.  People may participate in this clinical research trial if their study doctor has determined that they have a certain type of AF and require surgery to correct another heart problem other than AF. 

AtriCure’s Synergy Ablation System (“Study Device”) is approved by the FDA for use in patients with persistent AF (lasts longer than seven days, or lasts less than seven days but requires medicine or cardioversion) or longstanding persistent AF (lasts longer than a year) who are undergoing open heart surgery.

The purpose of this post-approval clinical study is to collect more data to continue to evaluate long-term safety and effectiveness of the Study Device now that it has been approved by the FDA.

A minimum of 350 patients with AF are expected to take part in the research trial at 50 hospitals across the United States.  If you agree to join the research trial, your participation will last three years (36 months) with 5 clinic visits after your surgery.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Carmen Diaz at (312) 926-4801 or e-mail cadiaz@nmh.org

REACT.COM: Rhythm Evaluation for AntiCoagulaTion with COntinuous Monitoring

Principal Investigator:
Rod Passman, MD (profile opens in new window)
IRB Project Number:
STU00064217
Description of Research Trial:

This study is recruiting patients that have a history of atrial fibrillation (AF) and have a Reveal XT® device implanted. AF is a condition where the upper chambers of the heart (the “atria”) beat irregularly and are uncoordinated, which sometimes leads to undesirable symptoms and can cause blood clots to form in the heart.  These clots, or pieces of these clots, can break away and block other blood vessels. If the clot blocks an artery (a type of blood vessel) in the brain it can cause a stroke.   

To reduce the risk of stroke, doctors prescribe an anticoagulant (a blood-thinning medication) that prevents the formation of blood clots in the body and has been proven to prevent strokes in patients with AF.  An example of an anticoagulant medication is Dabigatran or Pradaxa.  In addition, doctors also implant Insertable Cardiac Monitor devices (i.e., “Reveal® XT”) to help manage AF. The Reveal® XT, a small insertable cardiac monitor (ICM), continuously monitors the heart’s electrical activity for up to three years and offers a new opportunity to more closely monitor AF episodes, even from home. If an AF episode is recorded on the ICM, information can be sent to treating physicians over a standard phone line.

While daily anticoagulation has been demonstrated to reduce the risk of stroke in patients with AF it may be unnecessary in patients who have brief and/or infrequent episodes.  Intermittent anticoagulation guided by data transmitted from an ICM may reduce the amount of time patients need to take anticoagulation, which reduces the risk of bleeding associated with daily anticoagulation use while not exposing patients to an increased risk of stroke.  Thus, patients may derive the benefits of anticoagulation medications administered only during periods of AF while have a reduced risk of bleeding. 

The purpose of this study to assess the safety and effectiveness of treating patients with intermittent anticoagulation using FDA-approved oral anticoagulant medications guided by an AF-sensing implantable cardiac monitor (Reveal XT). 

Up to 75 subjects may take part in this study at 3 research centers. We hope to recruit 30 subjects here at Northwestern University. Participation in this research study may last 12 months to approximately 36 months. Subjects will be required to come to the clinic in the Galter Pavilion for visits at Baseline and follow up visits every 3 months for a minimum of 12 months and up to 24 months.

Research Trial Contact Information:

For more information, interested participants and clinicians may contact Anna Huskin at (312) 695-4067 or e-mail ahuskin@nmh.org or Carmen Diaz at (312) 926-4801 or e-mail cadiaz@nmh.org  

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This page last updated 

February 11, 2014
Feinberg School of Medicine home page

Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)
Feinberg School of Medicine
676 North Saint Clair Street, Suite 1700
Chicago, IL 60611-2969
Phone: (312) 926-4000
Email: heartresearch@northwestern.edu

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