Research Trials in the Center for Heart Rhythm Disorders

SHIELD-2: A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients with an Implantable Cardioverter Defibrillator Protocol #:  AZM-MD-302

This study is recruiting people who have an implantable cardioverter-defibrillator (ICD) for the treatment of an abnormal heartbeat known as a ventricular arrhythmia.  The symptoms associated with abnormal heartbeats and ICD treatment are often a cause of cardiovascular (heart-related) emergency room visits and hospitalizations. 

The main purpose of this study is to see if a drug called azimilide (the “study drug”), can help people with ICDs have fewer heart‑related emergency room visits and hospitalizations than people not taking the study drug. The study drug is investigational (experimental), which means it is not approved by the US Food and Drug Administration (FDA).  This study will compare the study drug with a placebo to see if taking the study drug is better than taking placebo.  The placebo is a tablet that looks like the study drug but has no drug or other active ingredients in it.

About 890 people will take part in this study at about 200 research study centers around the world.  About 150 of these centers are in North America (US and Canada).  We hope to have about 10 people in the study at Northwestern.

Participation in this study may last up to 58 weeks (13 months and 2 weeks) and require 12 visits. Women who are able to become pregnant will need to complete 6 additional visits during the study period for monthly pregnancy testing.  Your total time in the study may be less based on the number of people in the study at the time you join or at any time during the study. Your study staff will inform you if your participation time will be shortened as this information becomes available.

ABLATE AF Registry Trial: AtriCure Synergy Bipolar RF Energy Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery

The ABLATE-AF study is looking for patients diagnosed with a non-paroxysmal (does not resolve on its own within 7 days) form of atrial fibrillation (“AF”) who also need surgery to correct a heart problem other than 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. 

The surgical Maze procedure is the standard surgery for AF, in which the heart tissue is cut with a scalpel and sewed back together to create lines of scar tissue on the heart tissue and around the pulmonary veins. This scar tissue blocks the faulty electrical impulses that trigger AF episodes, preventing the AF from continuing.  Though the surgical Maze has been shown to be effective in controlling the return of AF, it is a long and difficult procedure.

The success of the surgical Maze procedure has encouraged surgeons to develop other ways of creating scar tissue on the heart other than cutting and sewing. The AtriCure Bipolar System (“study device”) uses bipolar radiofrequency (RF) energy to treat the heart tissue to form scars.  The lines of scar tissue made with this system also block the faulty electrical impulses that trigger AF, just like the scars formed by the surgical cuts described above.  The heart tissue is “ablated” by the RF energy during surgery.  “Ablation” is a process in which heat causes heart muscle cells to die in the area involved in the irregular heart rhythm.

A previous trial, which tested the safety and efficacy of the study device in 55 patients with AF, is complete and is being reviewed by the FDA.  The purpose of this study is to continue to collect data from more subjects. The same research questions that were asked in the previous trial will be the focus of this study. They are: 1) how safe the study device is during surgery for AF, and 2) how effective treatment using the study device is in treating AF.  The study device will be used along with standard techniques to perform the MAZE surgical procedure that is described in detail below. 

About 75 patients with AF are expected to take part in the study at up to 20 hospitals across the United States. If you agree to join the study, your participation will last up to three years (36 months).

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 Jade Irving at (312) 695-6826 or e-mail jirving@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 Elonia Martin at (312) 926-2671 or email elmartin@nmh.org.