Global clinical trial to treat heart disease includes Ocala Hospital
In a significant stride toward advancing cardiovascular care, HCA Florida Ocala Hospital has been selected to participate in a groundbreaking clinical trial to assess the safety and effectiveness of a next-generation heart valve implant.
The study formally launched on Aug. 12, 2025, as the first procedure was performed at HCA Florida Ocala Hospital. Its outcomes could help redefine treatment standards for aortic stenosis. Severe aortic stenosis is caused by a scarring or a buildup of calcium that occurs over time within the aortic valve opening to the heart, restricting the flow of oxygen-rich blood to the rest of the body. Some patients have aortic stenosis because of a congenital heart defect called a bicuspid aortic valve.
Aortic stenosis is a condition that affects millions of aging adults, and if left untreated, it will shorten a patient's lifespan and adversely their quality of life.
“This trial represents a major step forward in expanding access to minimally invasive valve replacement for a broader group of patients,” said Dr. Gregory von Mering, an interventional cardiologist who serves as the principal investigator for the Ocala trial. “We’re honored to contribute to this global effort right here in Ocala. Our participation reflects the strength of our clinical team and our commitment to bringing the most advanced therapies to our community.”
The clinical trial, sponsored by Abbott, will evaluate the safety and effectiveness of the Navitor™ Transcatheter Aortic Valve Implantation system in patients with severe aortic stenosis who are at low or intermediate surgical risk. Patients should speak with their physician if they think they might be a candidate for the trial.
Patients will be enrolled across more than 100 sites worldwide. For patients in North Central Florida, the trial is a powerful reminder that some of the most advanced heart care in the world is happening right in their own backyard.
“We are incredibly proud to be part of this clinical trial,” said Alan Keesee, chief executive officer of HCA Florida Ocala Hospital. “This opportunity places Ocala at the forefront of cardiovascular innovation and reflects our unwavering commitment to bringing world-class, research-driven care to our community.”
Lisa Tzanakis, chief operating officer of HCA Florida Ocala Hospital, echoed that sentiment. “Participating in this global study is a testament to the strength of our clinical teams and our dedication to advancing patient care,” said Tzanakis. “We’re excited to help shape the future of heart valve therapy right here in Ocala.”
If successful, the trial could lead to expanded approval by the U.S. Food and Drug Administration for use of the valve in lower-risk patients — potentially transforming the landscape of aortic valve replacement.
HCA Florida Ocala Hospital recently became part of the HCA Healthcare Research Institute, the clinical research arm of HCA Healthcare nationally. HCA Florida Ocala Hospital is the first site in North Central Florida to join the Research Institute, which has established 50 sites, including nine in Florida, throughout the company’s nationwide network. An estimated 3,000 patients are enrolled in more than 400 active trials.