Research Trials in the Center for Heart Rhythm Disorders

REVEAL-XT

The REVEAL-XT study is looking for patients who have atrial fibrillation and are scheduled to undergo surgery for treatment. 

Atrial fibrillation (AF) is an abnormal heart rhythm.  With atrial fibrillation, electrical impulses don't follow a normal pathway through the heart causing the upper chambers of the heart (atria) to beat too fast in a disorganized, irregular way. As a result, AF causes blood to be pumped improperly, resulting in pooling or clotting, which in turn increases the risk of stroke, heart failure and sudden cardiac death. Patients with AF may experience symptoms like pounding or fluttering in the chest, dizziness, fatigue, chest pain, and/or shortness of breath. The treatment of this disorder is relatively difficult as patients do not always experience symptoms and therefore AF often goes unnoticed by patients.

The purpose of this study is to monitor the heart’s rhythm after surgery using the Reveal XT^® Insertable Cardiac Monitor device (“Reveal XT”, study device).  The Reveal XT is the first FDA approved implantable heart monitor that provides continuous and long-term monitoring of the heart’s electrical activity. All other current monitoring tools are hooked-up outside the body (i.e. Holter monitor, electrocardiograms) and provide only intermittent data, whereas the study device can monitor patients 24 hours a day, every day for up to three years.  Since the study device is inserted just under the skin there are no restrictions to the patient’s daily activities. This is not only more comfortable, but also ensures that data recorded is not influenced by restrictions in activities. Since the device provides continuous monitoring, recurrent episodes of AF are more likely to be detected, which in turn means that the physician no longer needs to rely on incomplete data to evaluate the effectiveness of treatment.

Approximately 50 subjects will be enrolled in the study at 2 sites in the United States.  We hope to enroll up to 30 subjects here at Northwestern University.   Participation will require clinic visits at 1, 3, 6, and 12 months after surgery.

For more information, interested participants and clinicians may contact ulie Zaura at (312) 695-6826 or e-mail jzaura@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 ulie Zaura at (312) 695-6826 or e-mail jzaura@nmh.org. 

CRYptogenic STroke And underLying AF (Atrial Fibrillation) (CRYSTAL AF Study)

The purpose of the study is to see if patients who have suffered from a cryptogenic stroke or Transient Ischemic Attack (TIA) may benefit from timely AF detection available by use of the Reveal XT® Insertable Cardiac Monitor device ("Reveal XT"), the study device.  The study device, a small Insertable Cardiac Monitor (ICM), continuously monitors the heart's electrical activity for up to three years and offers a new opportunity to investigate the incidence of AF in patients with cryptogenic stroke or TIA.  Subjects will be required to come to the clinic at either Galter Pavilion or Feinberg Pavilion for visits at Baseline, Device Implant (if randomized to receive the device), and follow up visits at 1, 6, and 12 months, and every 6 months thereafter until follow-up is complete for all subjects in the study.

Up to 450 subjects may take part in this study.  We hope to recruit 10 subjects here at Northwestern University.  Participation in this research study may last 12 months to approximately 36 months.