CryoCor: Clinical Trials: Atrial Fibrillation

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Atrial Fibrillation

Atrial Flutter

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Atrial Fibrillation

Atrial fibrillation is by far the most commonly occurring cardiac arrhythmia affecting over 5.6 million individuals in the U.S. annually. Atrial fibrillation causes the upper chambers of the heart (atria) to beat at an irregular rate and in an irregular rhythm. This chaotic activity interrupts normal blood flow, predisposes the heart to the formation of blood clots and results in a 6x increase in stroke and a 2x increase in mortality. Over 80,000 strokes annually are caused by atrial fibrillation. Each year atrial fibrillation strikes more individuals than Parkinson's disease, epilepsy, and Alzheimer's' Disease combined.

Patients with atrial fibrillation report symptoms such as heart palpitations (a racing heart), fatigue, weakness, shortness of breath, chest pain, and light-headedness. The current standard of care in the treatment of atrial fibrillation is life-long drug therapy — typically agents used in the attempt to restore the heart to its normal rate and rhythm, and blood thinners to prevent blood clot formation. Unfortunately these drugs do not cure atrial fibrillation and they have sometimes severe side effects which include arrhythmias, blindness, depression, impotence, lung toxicity (pulmonary fibrosis), skin discoloration, hemorrhage, liver damage, thyroid damage, and even death.

Since episodes of atrial fibrillation are unpredictable, patients will often avoid travel, stop exercise, and shun visits with family and friends. This loss of quality of life affects not only atrial fibrillation patients, but their family and friends as well.

As an alternative to these ineffective medications, some clinicians use heat-based radiofrequency (RF) ablation devices to treat atrial fibrillation even though these devices are not approved for this use in the United States. Patient complications reported in literature from the use of RF ablation devices to treat atrial fibrillation have at times resulted in severe loss of health and even death. These complications include the narrowing of blood vessels between the lungs and the left atrium (pulmonary vein stenosis), the creation of stroke producing clots (emboli), and the creation of life-threatening openings between the heart and the esophagus (atrial esophageal fistulas). These complications of RF ablation have limited its use to treat atrial fibrillation in some settings.

CryoCor cryoablation has been used to treat over 1,800 individuals worldwide for atrial flutter, atrial fibrillation and other cardiac arrhythmias. Unlike RF ablation, no pulmonary vein stenosis has been noted to date in cryoablation clinical studies or commercial use, nor have there been reports of atrial esophageal fistulas. As a result, CryoCor believes its Cardiac Cryoablation System may provide clinicians with treatment success at least equivalent to that now achieved in treating atrial fibrillation with either drugs or RF ablation but with fewer patient complications.

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