Atrial fibrillation (AFib), is the most common treated heart arrhythmia, affecting over 6 million American adults. Sarasota Memorial’s Kolschowsky Research and Education Institute is participating in
the CONFORM Pivotal trial, evaluating a new investigational device that offers patients with AFib an alternative to long-term medication use. The study will help determine if the device is safer and more effective than other commercially available devices for left atrial appendage (LAA) occlusion or closure.
Led locally by cardiac electrophysiologist Robert Eckart, DO, the multi-center trial will evaluate the CLAAS® system—a permanent implant in the left atrial appendage designed to seal off the LAA, a small pouch in the heart where clots often form, and lower the risk of stroke without the need of blood thinners. The CLAAS® system is intended to simplify the procedure and enhance safety for patients by utilizing a foam-based implant designed to conform to each patient's unique anatomy.
The study sponsored by Conformal Medical Inc. is slated to enroll 1,600 patients at up to 100 sites in North America, Europe, and Central Asia. Eligible participants must be at least 18 or older with non-valvular AFib and currently taking blood thinners. They must be deemed appropriate by their doctors for left atrial appendage occlusion or closure.
For more information or to find out if you are eligible to participate in the local study, contact the research team at (941) 917-2225 or researchinstitute@smh.com. For information about the national trial, visit: https://www.clinicaltrials.gov/study/NCT05147792.