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Banner Good Samaritan opens clinical trial for minimally-invasive cryoablation procedure to relieve atrial fibrillation

 

Dr. Su
Dr. Wilber Su in the Electrophysiology Lab
performing a CryoCath procedure.

PHOENIX (May 5, 2008) – A new procedure to relieve atrial fibrillation in the heart will begin clinical trials in Arizona at Banner Good Samaritan Medical Center.

The Cryo System Trial Of Paroxysmal Atrial Fibrillation (STOP AF) trial is being conducted at 28 hospitals across the United States and Canada. At Banner Good Samaritan the trial will be conducted by cardiologist and cardiac electrophysiologist Dr. Wilber Su, medical director of the Atrial Fibrillation Center at the hospital's Cavanagh Cardiology Center.

Atrial fibrillation (AF), described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 2.3 million patients in the U.S. with an annual incidence of 170,000 new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. If left untreated, it can lead to heart failure and death.

Cardiac Electrophysiologists have found that the electrical currents that cause atrial fibrillation can be disrupted by ablation (burning) the heart muscle along these electrical pathways, thus allowing the heart to beat at a normal rhythm. The ablation process is usually delivered with a laser device or electrical current. Recent innovations have allowed interventional cardiac electrophysiologogists to investigate an approach to atrial fibrillation cases internally through a minimally-invasive catheterization procedure. At the present moment, there are no catheters approved by the Food and Drug Administration to treat atrial fibrillation coming from the pulmonary veins.

The STOP AF trial utilizes the Arctic Front cryo-balloon catheter designed by CryoCath® Technologies, Inc., to specifically treat AF. Once the catheter is placed in the heart’s interior chambers, the cardiac electrophysiologist delivers liquid nitrous oxide to the heart via a small balloon. As the nitrous oxide refrigerant is vaporized, inside the balloon, it freezes the tissue creating a lesion in the areas of the heart causing AF, rather than burning it. Cryoablation as an ablative modality is already well known to cardiac electrophysiologists as being less disruptive to the cardiac tissue that electrical current or radiofrequency energy. 

-46
Temperatures as low as -46 F freeze the heart
tissue and stop atrial fibrillation with less
damage to surrounding heart muscle than
traditional forms of ablation.
The goal of the STOP AF trial is to demonstrate Arctic Front’s safety and effectiveness for the treatment of Paroxysmal Atrial Fibrillation (PAF) when compared to traditional anti-arrhythmic drug therapy. As many as 270 patients, randomized into two arms, will be enrolled to complete the trial. One group will receive cryoablation therapy with Arctic Front (the ablation arm); the other will receive currently prescribed drug therapies (the control arm). For every two patients in the ablation arm, there will be one in the control arm. Patients in the trial will be highly symptomatic paroxysmal AF patients who have failed at least one anti-arrhythmic drug. The trial’s primary endpoint will be the absence of detectable AF at the end of the 12-month follow up period. The trial’s design also allows patients randomized into the drug arm to cross over into the ablation arm if they do not show improvement. Once the follow up period is completed, CryoCath will file a Pre-Market Approval (PMA) application to the FDA with the intent to obtain approval for the Arctic Front system for the treatment of PAF.

CryoCath is a medical technology company that leads the world in cryotherapy products to treat cardiac arrhythmias. With a priority focus on providing physicians with a complete solution of catheter products to treat cardiac arrhythmias, CryoCath has multiple products approved in the U.S., across Europe and several ROW countries. The Company is developing additional products to expand its pipeline of products to treat cardiac arrhythmias.

Banner Good Samaritan Medical Center has been providing medical care to Arizona and the Southwest since 1911. Banner Good Samaritan is owned and operated by Phoenix-based Banner Health, a not-for-profit organization, and is a flagship hospital within the system. The hospital was recently named to U.S.News & World Report’s “America’s Best Hospitals” list for Gynecology, Heart and Heart Surgery, Kidney Disease and Urology. Banner Good Samaritan has been recognized as a Magnet facility by the American Nurses Credentialing Center, the highest honor a hospital can earn for its nursing care and practices.

Contact:
Banner Good Samaritan Public Relations
(602) 239-4411
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