Research Trials in the Center for Heart Rhythm Disorders

ProMRI

The ProMRI study is recruiting patients who have been implanted with a Pacemaker System (specifically, an Entovis pacemaker and one or two Setrox S pacing leads) at least five (5) weeks ago. The purpose of this study is to see if an MRI scan can be conducted safely on patients implanted with this pacemaker system, if certain conditions and precautions are taken.

Magnetic Resonance Imaging (MRI) is a routine, non-invasive test that uses high energy magnetic fields and radio waves to produce images of the inside of the body.  When a doctor looks at these images, he/she can gather information that can be used to diagnose certain diseases of the body.

In the past patients who needed an MRI scan could not have one if they had been previously implanted with a pacemaker or similar device. The strong electrical and magnetic energy present during an MRI scan could damage certain types of pacemakers.

The Entovis pacemaker and the Setrox S lead are approved by the U.S. Food and Drug Administration (FDA) for use in the general public.  However, the FDA has not approved these devices for use during an MRI scan.

Patient’s participation in this study is expected to last about 3 months and would involve 1 MRI scan and up to four (4) visits.  The study investigators hope to enroll 10 subjects at Northwestern University and 245 nationwide. Compensation is provided for transportation and the participant’s time.

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

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).

Acute Multi-Signal Data Collection Study

The AMSD study is looking for patients who have a Medtronic Cardiac Resynchronization Therapy (CRT-D) or dual-chamber implantable cardioverter-defibrillator (ICD) device and leads (insulated wires that carry electrical signals between the device and your heart), and will be having an electrophysiology (EP) study or a heart ablation procedure as part of their routine medical care.

The purpose of this study is to record and collect heart beat data and heart sounds from a patient’s implanted CRT-D or 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 CRT-D and ICD devices.

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

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.

For more information, interested participants and clinicians may contact the Clinical Trials Unit at (312) 926-4000 or e-mail heartresearch@northwestern.edu 

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

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.

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

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.

REACT.COM: Rhythm Evaluation for AntiCoagulaTion with COntinuous Monitoring

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.

For more information, interested participants and clinicians may contact Dr Rod Passman at (312) 926-2148 or the research nurse, Carol Ann Aguirre at (312) 926-7554 or e-mail caguirre@nmh.org  

LAA Occlusion: Evaluation of surgical techniques

This study is enrolling patients that are scheduled to have cardiac surgery and closure of the left atrial appendage (LAA) during surgery.

The LAA is a part of the heart that serves as a reservoir (container) for blood flowing in and out of the left ventricle.  As the blood flows in and out of the LAA sometimes the blood becomes trapped in the area and forms a blood clot, which could potentially increase the chances of having a stroke.  A stroke occurs when a blood vessel (a tube through which the blood moves through the body) breaks or a clot blocks an artery (a blood vessel that carries blood from the heart to the body), interrupting blood flow to an area of the brain.

The purpose of this study is to evaluate three (3) different surgical techniques routinely used to occlude (close off) the LAA: stapling, surgical removal (excision) and internal ligation.  Each of these techniques are routinely performed during surgery to stop blood from moving in and out of the LAA, potentially reducing the formation of blood clots, and are not experimental.

Participation in the study will last for one year and will involve one (1) follow-up visit and two (2) follow-up phone calls.

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