SMH participating in global atrial fibrillation device trial

Sarasota Memorial Hospital’s Kolschowsky Research and Education Institute is participating in a clinical trial of a new device to treat atrial fibrillation (A-fib), the most commonly treated heart arrhythmia.

Called the Conform Pivotal Trial, the instrument is an investigational device that offers patients with A-fib 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.

Image courtesy of Sarasota Memorial Hospital

Led locally by cardiac electrophysiologist Dr. Robert Eckart, 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. 

The 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 and lower the risk of stroke without the need of blood thinners.

The study, sponsored by Conformal Medical Inc., could enroll 1,600 patients at as many as 100 sites in North America, Europe and Central Asia. Eligible participants must be at least 18 or older with non-valvular A-fib and currently taking blood thinners. Their doctors must deem them appropriate for left atrial appendage occlusion or closure.

For more information about eligibility requirements, contact the research team at 941-917-2225 or [email protected].