TCAI physicians participate in clinical trial for potential life-saving device for patients with heart rhythm disorders
PR87964
AUSTIN, Texas, Feb. 5, 2021 /PRNewswire=KYODO JBN/ --
Physicians with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's
Medical Center [
are among the first in the world to participate in a clinical trial to
evaluate a new esophageal protection device designed to make ablation
procedures safer for patients with atrial fibrillation (A Fib), the most common
type of cardiac arrhythmia. Andrea Natale, M.D., F.H.R.S., F.A.C.C., F.E.S.C.,
cardiac electrophysiologist and executive medical director of TCAI, and Amin
Al-Ahmad, M.D., cardiac electrophysiologist at TCAI, recently participated in
the first-in-human trials in Europe.
Given the close proximity of the esophagus to the posterior wall of the left
atrium of the heart, thermal energy may enter into the esophagus during
ablation, causing an atrio-esophageal (AE) fistula, which is an abnormal
connection between the esophagus and atrium. It is among the most serious and
life-threatening complications from ablation. This device works by using
suction to pull the esophagus away using negative pressure during ablation
procedures.
"While esophageal injury is uncommon during ablation, perforation of the
esophagus can lead to sepsis, which is often fatal," Dr. Natale said. "This new
device may allow us to better protect the esophagus during ablation, further
reducing the risk of complication to ensure best possible outcomes for our
patients."
TCAI physicians tested the esophageal protection device on approximately 10
patients in Europe, with plans to make it available to TCAI patients upon FDA
approval. This technology could be available in the United States in two to
three years.
Media Contact:
Stacy Slayden
Elizabeth Christian Public Relations
SSlayden@EChristianPR.com
254.592.2767 cell
SOURCE: Texas Cardiac Arrhythmia Institute at St. David's Medical Center
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