CryoCor: Clinical Trials: Atrial Flutter

Overview

Atrial Fibrillation

Atrial Flutter

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Atrial Flutter

Atrial Flutter is a heart rhythm disorder in which the upper chambers of the heart (the atria) beat up to 5x faster than normal. Because the heart does not pump as well under these conditions, blood clots can form putting individuals with atrial flutter at increased risk of stroke. Symptoms associated with atrial flutter include palpitations (a racing heart beat), shortness of breath, chest tightness, fatigue and dizziness. Some individuals experience no symptoms at all. Although episodes of atrial flutter can come and go quickly, it can also be a chronic, life-long condition. It is estimated that more than 200,000 new cases of atrial flutter occur annually in the U.S.

Treatment options for atrial flutter include cardioversion (electrical shock), daily medication, and one-time ablation therapy. Cardioversion typically restores normal heart rhythm for a time, but atrial flutter usually returns. Drug therapy frequently fails to stop episodes of atrial flutter and can have unwanted side effects. An alternative to cardioversion or drug therapy is cardiac ablation. Cardiac ablation is a minimally invasive, non-surgical procedure in which a catheter is inserted into a blood vessel in the leg and advanced until it reaches the tissue in the heart conducting the signals causing the heart to beat abnormally.

Current cardiac ablation catheters use radiofrequency (heat-based) energy to raise tissue temperature between 50° to 100° Celsius (122° to 212° Fahrenheit) to block abnormal signal conduction. Although achieving 90%+ success in terminating atrial flutter, complications reported with RF / heat-based ablation devices have included tissue damage and tearing due to popping of gas bubbles, tissue charring and blood clot formation.

CryoCor cryoablation has been used to treat over 1,800 individuals worldwide for atrial flutter, atrial fibrillation and other cardiac arrhythmias. CryoCor believes its Cardiac Cryoablation System will provide clinicians with treatment success at least equivalent to that now achieved in treating atrial flutter without these heat-related patient complications.

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