Thousand Oaks, Calif.-based Los Robles Health System, part of Nashville, Tenn.-based HCA Healthcare, was among the top 10 sites for patient enrollment in a clinical trial aimed at assessing the safety and effectiveness of Abbott’s TriClip Transcatheter Tricuspid Valve Repair system.
Results from the TRILUMINATE Pivotal trial, in which surgeons performed transcatheter edge-to-edge repair for severe tricuspid regurgitation with Abbott’s TripClip system, were published March 30 in Circulation.
Los Robles was the top site for patient enrollment within HCA Healthcare and enrolled more patients than some of the leading academic sites in the country, according to a June 10 news release from the health system.
Saibal Kar, MD, interventional cardiologist and director of structural heart disease interventions and clinical research at Los Robles, shared more with Becker’s about participating in the trial and what it meant for the health system to be one of the trial’s top enrollment sites.
Editor’s note: Responses have been lightly edited for clarity and length.
Question: What strategic considerations led Los Robles Health System to prioritize participation in a large-scale clinical trial like TRILUMINATE?
Dr. Saibal Kar: Los Robles Health System strives to be a center of excellence and provides an infrastructure to perform advanced procedures, including those related to cardiovascular care. We are a regional destination for care that [aims] to provide our patients and community with the latest treatment options that are close to home.
This is the first tricuspid repair system to be FDA approved. I was personally involved as a member of the steering committee of this large multicenter clinical trial that focused on evaluating the efficacy and safety of transcatheter tricuspid valve repair for severe tricuspid regurgitation for patients that were moderate to high risk for open heart surgery.
As a result of the study, Los Robles is an important referral center for this novel procedure in this region.
Q: Being a top enrolling site — especially within a large network like HCA Healthcare — requires significant operational coordination. What were the key factors that enabled Los Robles to outperform even major academic centers in trial enrollment?
SK: First, the support of Los Robles Health System’s administrative team and the power of the HCA Healthcare Research Institute have been key factors in the success of our clinical trial program.
Prior to joining the HCA Healthcare network, I was a physician at Cedars-Sinai Medical Center. My experience at Cedars-Sinai helped me organize a heart team at Los Robles that excels in clinical trials. My approach with the team was to educate them on how these novel procedures offer solutions to patients that cannot seek traditional treatment options. We truly have the chance to pave the way in healthcare and deliver hope to patients each day.
Specifically, I trained echocardiographers, cardiac anesthesiologists and heart failure specialists to execute this clinical trial successfully. This was a true team effort. In addition, HCA Healthcare has a strong research team to help with the logistics of each clinical trial.
Q: Looking ahead, how is Los Robles preparing its infrastructure, care teams and partnerships to support the wider adoption of transcatheter therapies?
SK: The success of this trial has attracted leading medical companies to work with our heart team for the evaluation of novel transcatheter valve procedures. We are now participating in numerous clinical trials involving transcatheter treatment options for valvular heart disease.
As we look to the future, we are working to provide education and information to providers in our region that are currently treating some of our most vulnerable cardiac patients. Solutions for patients that do not have much hope are out there, and our team is working hard to continue to advance research and solutions for the treatment of cardiovascular disease.
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