Tuesday, March 08, 2011
Winchester Medical Center Selected as One of 10 U.S. Sites to Use Robotic Catheter Technology in FDA Clinical Trial
Electrophysiologist Ejaz Khan, MD, FACC, welcomed a new player to his specialized cardiology team at Winchester Medical Center in mid-February. Known as the Amigo, the new assistant works efficiently and independently, with proper guidance, to map electrical activity in the heart.
The Amigo Remote Catheter System is a robotic catheter navigation device under investigation at 10 facilities in the U.S. as part of an FDA clinical trial to determine its safety and efficacy for cardiac mapping procedures on the right side of the heart (NCT 01139814). The device is already approved in Europe for this use.
Mapping is the crucial first step in treating electrical disturbances of the heart through ablation, a procedure which uses radio-wave frequency to remove tissue that causes the heart to beat too fast or in an irregular way. Dr. Khan has performed nearly 200 ablation procedures each year since moving to Winchester in 2008 as the first and only electrophysiologist in the region.
About 5-6% of people with heart disease have arrhythmias. Untreated, arrhythmias can cause severe, disabling symptoms and sudden cardiac death. “Ablation can cure their arrhythmia and give them their lives back,” Khan says. Future clinical trials will investigate using the Amigo for ablation procedures.
The ability to visualize the heart noninvasively relies on radiologic imaging using short bursts of low-dose radiation. The patient’s exposure is only slight and very safe, but lab staff must wear protective lead aprons to minimize exposure. Being able to control the catheter by sitting or standing up to 100 feet away, out of the radiation field, can greatly reduce radiation exposure and fatigue, particularly during a lengthy case.
“The robot actually makes it safer for the patient and physician,” says Dr. Khan. “The Amigo can accomplish in 3-5 minutes what it takes me 20 minutes to do. It spares me the exposure to radiation and the robot is much more precise in mapping cardiac arrhythmia. It still follows my orders,” he explains, “but makes it quicker, simpler, easier and safer for the patient and me.”
The Amigo clinical trial is one of 30 currently being managed by the Valley Health Clinical Research Department. Since the department’s inception in 2004 there have been close to 90 trials conducted in the Winchester area. The department employs five full-time research nurses who are fluent in the FDA regulations guiding investigational drug and device trials.
“Providing the infrastructure and knowledge base allows busy private practice physicians like Dr. Khan to participate in cutting-edge clinical trials, which is helping advance science and technology,” explains Jennifer Stanford, RN, MSN, Director of Valley Health Clinical Research.
To participate in the Amigo trial, patients must meet certain criteria. For more information on the Amigo trial, contact: Jennifer Stanford, RN, MSN at 540-536-8978 or via email at email@example.com.