Sarasota Memorial Participating in Three Pivotal Studies for Patients with Failing Heart Valves

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Sarasota Memorial is participating in three (3) global clinical trials evaluating minimally invasive treatment options for patients with cardiac valve disorders. Led by Interventional Cardiologist Ricardo Yaryura, MD, and coordinated by the Sarasota Memorial Research Institute, the key objective of the trials is to evaluate the safety and efficacy of transcatheter valve replacement with Edwards Lifesciences devices in the mitral, aortic and tricuspid spaces. This research offers an opportunity to further examine novel treatment options, in an effort to continuously provide patients with optimal care.​ Patients with cardiac damage and dysfunction are vulnerable and as their disease worsens, the risk of life-threatening adverse events increases (e.g., stroke and heart failure). Treatment options for patients with severe cardiac valve insufficiencies typically require surgical repair or replacements. However, many patients with valve complications are not eligible for surgical treatments, due to age or pre-existing medical conditions, and may benefit from having the option for a minimally invasive procedure. The following trials are currently under way and open for enrollment at SMHCS: The ENCIRCLE Trial – The ENCIRCLE study evaluates the safety and efficacy of the investigational Edwards SAPIEN M3 system, a transcatheter procedure developed to replace the mitral heart valve in patients with severe mitral valve regurgitation who do not qualify for other treatment options. The study is taking place at up to 75 institutions worldwide and slated to treat up to 500 patients; The PROGRESS Trial– The PROGRESS study is being conducted examine transcatheter aortic valve replacement (TAVR) versus careful Clinical Surveillance (CS) in patients with moderate aortic stenosis and at least one additional risk factor. The study will help determine if some patients benefit from having their aortic valve replaced before their condition progresses to severe aortic stenosis. Patients who have already been diagnosed with severe aortic stenosis, meeting regional guidelines for the timing of intervention (i.e., ACC/AHA), can receive FDA approved, commercially available treatment options and would not qualify for this study. Up to 80 global centers will enroll up to 750 patients. Eligible patients will be randomized to either (1) TAVR with the Edwards SAPIEN 3 or SAPIEN 3 Ultra transcatheter heart valve or (2) Clinical Surveillance (CS). Study patients randomized to CS will be followed annually, for up to 10 years. Close follow-up will allow structural valve disease experts to determine whether guideline-recommended criteria for the timing of aortic stenosis intervention is met, making CS patients eligible for AVR; Clasp II TR Trial – The Clasp II TR study evaluates the safety and effectiveness of Edwards’ investigational PASCAL Transcatheter Valve Repair System, which is designed to repair the tricuspid valve in patients with tricuspid valve regurgitation. The study is taking place in up to 75 institutions worldwide and slated to enroll up to 825 patients to compare the benefits of those who receive Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy, compared to optimal medical therapy alone. For more information about these cardiac valve studies or other clinical trials, contact the Sarasota Memorial Research Institute at (941) 917-2225. For a physician referral or information about cardiac care at Sarasota Memorial, call (941) 917-7777 or visit smh.com/heart.

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