Beaumont First in Michigan to Participate in National Research Study of New Atrial Fibrillation Treatment
Beaumont Health System has enrolled its first patients in a multicenter, randomized research trial to study a new technology to treat atrial fibrillation, the most common heart rhythm disorder, affecting 2.3 million people in the U.S.
HeartLight® Endoscopic Ablation System
Called the HeartLight® Endoscopic Ablation System, it is the first technology that allows cardiologists to see inside a beating heart while performing laser energy catheter ablation, a treatment aimed at restoring normal heart rhythm after medication has failed. Beaumont is the only center in Michigan participating in this study and one of the first in the U.S. to begin enrollment.
The trial will compare the effectiveness of the new HeartLight EAS, using laser (light) energy to heat and destroy heart tissue to block erratic electrical signals causing a-fib, with traditional catheter ablation systems that use radiofrequency (electrical) energy.
The HeartLight incorporates a small camera, or endoscope, that allows cardiologists to see inside a beating heart on a monitor to more precisely deliver the ablation energy. While the technology is only available at trial sites in the U.S., it is currently used at medical centers throughout Europe.
“As a leader in the treatment of atrial fibrillation, we are pleased to be involved in testing this new treatment that may benefit our patients, and ultimately a-fib patients throughout the country,” says Ilana Kutinsky, D.O, Beaumont electrophysiologist and principal investigator. “Beaumont has been involved with research of the HeartLight EAS technology since the initial U.S. feasibility trial in 2010, and we are pleased to be involved in this important step in the Food and Drug Administration approval process.
Beaumont plans to enroll 43 patients in the study who have paroxysmal (intermittent) atrial fibrillation. They will be randomized to receive treatment with the HeartLight, or to have standard radiofrequency ablation. A total of about 350 participants will be randomly enrolled in the study, at up to 25 centers in the U.S. The results of the two groups will be compared.
“What makes this device unique is its ability to allow doctors to directly see inside the heart in real-time while performing the ablation, which may reduce the likelihood that a patient will need a repeat procedure,” explains Dr. Kutinsky. “Traditional ablation does not provide direct visual guidance.”
To qualify for study participation, patients must be 18 to 75 years of age, have intermittent atrial fibrillation and have failed treatment with anti-arrhythmic drugs.
Participants will receive a medical history; physical exam; an electrocardiogram (showing the heart’s electrical activity);a transthoracic echocardiogram (an ultrasound picture of the heart); a CT scan or magnetic resonance imaging (to show heart structures) and blood tests.
For more information on the study please visit http://clinicaltrials.gov/show/NCT01456000.
For enrollment information, please call the Beaumont Atrial Fibrillation Center at 248-898-6575.
Source: Beaumont Health System