Clinical Accelerator, a clinical trial management organization, is partnering with Tau Medical to conduct an Early Feasibility Study (EFS) of the 'Pivot Extend' device, an investigational medical device designed for treating tricuspid regurgitation (TR). Clinical Accelerator will function as the Contract Research Organization (CRO) for this study, which will be located in the Republic of Georgia.
The study aims to evaluate the safety and demonstrate the efficacy of the Pivot Extend device in alleviating symptoms of TR in patients suffering from severe and clinically symptomatic tricuspid regurgitation. The long-term implantation of the Pivot Extend device represents a promising approach to managing TR, potentially providing relief to patients who have exhausted other treatment options.
Tricuspid Regurgitation and the Need for New Treatments
Tricuspid regurgitation is a condition where the tricuspid valve does not close properly, causing blood to flow backward into the right atrium. Severe TR can lead to chronic right heart failure. Despite the prevalence of TR, effective treatment options have been limited, particularly for patients who are not suitable candidates for surgical intervention. Clinical trials like the Pivot Extend EFS are crucial for advancing treatment options for TR. By evaluating new, less invasive approaches, these studies offer hope for improved patient outcomes, especially for those with severe symptoms.
Study Design and Objectives
The Early Feasibility Study will assess the safety and initial efficacy of the Pivot Extend device in a select patient population. The study will focus on patients with severe and clinically symptomatic tricuspid regurgitation who are not candidates for traditional surgical approaches. The primary endpoint will likely focus on device safety and performance, with secondary endpoints assessing improvements in TR severity, functional capacity, and quality of life. Further details regarding specific endpoints and patient inclusion criteria will be available as the study progresses.
About Clinical Accelerator
Clinical Accelerator specializes in implementing early-stage First-In-Human (FIH) and Early Feasibility Studies (EFS) with a focus on rapid patient enrollment and high-quality data collection within compact timelines. The company operates in Central and Eastern Europe and Central Asia and is dedicated to supporting the advancement of innovative medical treatments through rigorous and well-executed clinical trials.
