SAN JOSE, Calif.--(BUSINESS WIRE)--VitalConnect®, Inc., a leader in remote and in-hospital wearable biosensor technology, announced today that it has begun the TELESTAR-TAVR clinical study (Deployment of Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients).
The TELESTAR-TAVR Study will evaluate patients who undergo a transcatheter aortic valve replacement (TAVR) and monitor them following the procedure utilizing the latest technology from VitalConnect, VistaSolution LIVE. The primary objective of this prospective trial is to measure the impact of remote patient monitoring (RPM) and telehealth on patient satisfaction, clinical outcomes, and readmission rates for patients.
According to data from the Nationwide Readmissions Database, all-cause thirty-day readmission ranged from 14.6% to 20.9% for TAVR patients, with non-cardiac causes accounting for 61.8% and cardiac causes account for 38.2% of readmissions. A retrospective analysis of 8,073 patients, who underwent TAVR, identified arrhythmia (tachyarrhythmias and atrial fibrillation), as one of the most prominent cardiac predictors for readmission. VistaSolution LIVE provides continuous, real-time monitoring and detection of cardiac arrhythmias. VistaSolution LIVE can also monitor up to 11 unique patient vitals, such as heart rate, respiratory rate, body temperature, and activity. This information may aid providers to monitor early signs of deterioration, predict possible complications, and adjust treatment strategy to optimize clinical outcomes.
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“The TELESTAR-TAVR study is a first-of-its-kind evaluation of the role remote patient monitoring may play in improving clinical outcomes and bringing new efficiencies to patient care,” said Brijeshwar Maini MD, FACC, National Medical Director of Cardiology at Tenet Healthcare and Professor of Medicine at Florida Atlantic University. “We’re looking forward to the results of this study and the impact that RPM may have on optimizing clinical outcomes and increasing patient satisfaction following TAVR.”
TELESTAR-TAVR will enroll a total of 100 patients, 50 each in the control and treatment groups, with initial study results available in six months and complete study results in 12 months. Patients will be discharged within 24 hours of their procedure, monitored for seven days with the VitalPatch RTM biosensor and then connect with their physician via secured video call using the VistaSolution LIVE at seven, fourteen and twenty-one days. Patients will then return to the hospital for an in-person follow-up visit at 30 days.