Through its clinical trials leadership, Novant Health Presbyterian Medical Center is redefining treatment options for patients with atrial fibrillation.

Novant Health Presbyterian Medical Center, through the Novant Health Heart & Vascular Institute, was selected as one of the first clinical trial sites in the U.S. to use an innovative new model of an established implant device that helps patients with atrial fibrillation, or AFib.

The WATCHMAN FLX Pro Device helps patients with AFib reduce their stroke risk and need for blood thinner medication. WATCHMAN implants, manufactured by Boston Scientific, have been used to treat AFib for more than 20 years – and Presbyterian Medical Center has offered WATCHMAN devices to patients since 2016. What makes this new model different from previous models is that it is coated with a solution that prevents blood clots from attaching to the metal device that’s implanted inside the patient’s body. Since the new device reduces the risk of blood clots, it has the potential to reduce the amount of blood thinners needed after device implant.

Novant Health Heart & Vascular Institute is participating in the WATCHMAN FLX Pro Device national clinical trial, held at 60 sites.

“We're excited to be part of this trial and be one of the early sites to use this device because it's a leap in technology,” said Oluseun Olukayode Alli, MD, interventional cardiologist for Novant Health Heart & Vascular Institute in the greater Charlotte area. “The biggest benefit of this device is the fact that it can (or may) reduces certain patient’s stroke risk and they may be able to eliminate the risks associated with blood thinners. This technology can help them live happier, easier lives.”

Daniel Ke Pu, MD, interventional cardiologist, and Kevin Hsu, MD, clinical cardiac electrophysiologist, also perform WATCHMAN implants. Besides offering implants, cardiologists at Presbyterian Medical Center offer many treatment options to help patients manage the disease. Methods include medication, cardioversion, catheter ablation and pacemakers.

Reducing the connection between AFib and stroke

AFib is an irregular heart rhythm. An irregular heartbeat can cause blood clots, increasing the risk of having a stroke. That is why patients with AFib are three to five times more likely than an average person to suffer from a stroke. This disease is typically treated with blood thinner medication to prevent strokes. But over time, blood thinner medication can lead to other risks, like blood clots or bleeding. And not every patient is eligible to take a blood thinner, especially if they’re elderly or have comorbidities.

The most common type of AFib is non-valvular AFib, which means AFib appears without any underlying disease but can be caused by other things, such as high blood pressure, sleep apnea or hyperthyroidism. There are several types of AFib, such as paroxysmal AFib (something that happens occasionally) or chronic AFib (something that doesn’t go away).

Tailoring care plans and research initiatives to the benefit of patients

At Presbyterian Medical Center, our expert cardiologists and heart and vascular care teams are ready to guide patients on their journey to a healthier lifestyle through innovative heart care and leading-edge procedures. Here’s a look at the types of procedures conducted since 2022 to treat patients with AFib.

• Atrial fibrillation ablations – 420
• Ablation for supraventricular tachycardias – 70
• Atrioventricular (AV) node ablations – 47
• Permanent pacemaker implants – 355
• Biventricular permanent pacemakers – 49
• Implantable loop recorder for arrhythmia monitoring – 78

Novant Health Heart & Vascular Institute prides itself on the amount of research doctors do in the field. For example, Dr. Alli is the coordinating co-principal investigator for HEAL LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device study. He’s also been involved with several structural heart studies, including:

• Encircle (Safety and effectiveness of SAPIEN M3 System Transcatheter Mitral Valve Replacement via Transseptal Access)
• Summit (Safety and effectiveness of Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation)
• TRILUMINATE (Safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation)
• Alliance study (Safety and effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve)

Presbyterian Medical Center, Institute showcase top-performing work in heart and vascular clinical trials

As a leader in national and international cardiovascular research, Novant Health Heart & Vascular Institute serves as a top-performing cardiovascular investigative site and participates in many clinical trials. Nationally recognized for cardiac care, the Novant Health Heart & Vascular Institute uses a comprehensive, innovative approach to diagnose and treat heart and vascular conditions.

By being selected as the first clinical trial site for the WATCHMAN FLX Pro Device, Novant Health heart and vascular experts are offering patients a permanent solution to fix AFib.

“It gives me a lot of pride to work for an institution where I get to help be a part of this groundbreaking work,” Dr. Alli said.

“Novant Health continues to push the boundaries in research. We collaborate with external partners and industry partners, not only to do research, but to provide lifesaving therapies for our patients.”