The MemorialCare Heart & Vascular Institute at Long Beach Medical Center is the only hospital in Southern California — and one of only four sites in all of California — participating in the Dual Epicardial and Endocardial Procedure clinical trial (DEEP). The trial is a prospective, multi-center, single-arm, investigational device exempt (IDE) study to evaluate the safety and efficacy of the DEEP procedure in treating persistent and long-standing persistent atrial fibrillation, or AFib. The other three participating sites are based in Northern California.
The DEEP procedure utilizes the specialized skills of both the cardiovascular surgeon and electrophysiologist for more severe cases of AFib, which have historically been the most difficult patients to treat.
“It is important to understand that currently patients with persistent or long-standing AFib don’t have a viable alternative for treatment,” says Ali Khoynezhad, M.D., director, aortic and arrhythmia surgery, MemorialCare Heart & Vascular Institute, Long Beach Medical Center, and one of the three lead principal investigators for the trial. “The success rate of catheter ablation in persistent or long-standing AFib patients is around 30 - 40 percent, and if they undergo multiple catheter ablation procedures it can come up to 50 - 60 percent.”
This DEEP trial can help confirm that the hybrid atrial fibrillation approach is ideal for someone who has persistent or long-standing AFib and should be considered as a treatment option. By incorporating an electrophysiology cardiologist’s input and expertise along with that of a cardiovascular surgeon, the patient benefits from the strength of a minimally invasive surgical approach and a catheter ablation.
“The hybrid approach using the DEEP clinical trial has a success rate between 70 - 85 percent, which is a much needed improvement in treating patients with persistent or long-standing AFib,” says Dr. Khoynezhad. “This hybrid approach in a multi-center trial can help future patients know what approach is best for them.”
“The MemorialCare Heart & Vascular Institute at Long Beach Medical Center is committed to less invasive approaches to treat all types of cardiovascular disease,” says Marc Sakwa, M.D., medical director, adult cardiovascular surgery, MemorialCare Heart & Vascular Institute, Long Beach Medical Center. “This is another step forward in that direction, proving our commitment to less invasive treatments.”
“The DEEP trial reinforces AtriCure’s commitment to continue to expand the presence in minimally invasive treatment of persistent and long-standing persistent AFib patients and to improve the lives of these difficult to treat patients,” says Michael Carrel, president and chief executive officer, AtriCure. “We’ve worked very closely with the FDA and with our investigators to do everything we can to ensure a safe, effective and repeatable procedure.”
Up to 220 patients will be enrolled at up to 30 hospitals. Currently, more than 65 patients have been treated in the trial.