VitalConnect has announced the commencement of the TELESTAR-TAVR clinical study—Deployment of Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients)—monitoring patients undergoing transcatheter aortic valve replacement (TAVR) using VitalConnect’s VistaSolution LIVE technology. The trial has a primary objective of measuring 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, VitalConnect said in a press release. This information may aid providers to monitor early signs of deterioration, predict possible complications, and adjust treatment strategy to optimise clinical outcomes.
“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 (Florida Atlantic University, Boca Raton, USA). “We’re looking forward to the results of this study and the impact that RPM may have on optimising clinical outcomes and increasing patient satisfaction following TAVR.”
TELESTAR-TAVR will enrol 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.
“VitalConnect continues to expand the use of our technology to advance patient care and outcomes in multiple modalities within healthcare and we expect the TELESTAR-TAVR trial to demonstrate our proficiency in the growing TAVR space,” said Peter Van Haur, CEO of VitalConnect. “VistaSolution LIVE uses our latest generation VitalPatch RTM biosensor to monitor patients for cardiac arrhythmia and signs of deterioration in real-time, providing physicians and their patients a higher level of confidence during the recovery process post-TAVR.
VitalConnect’s VistaSolution LIVE consists of a wireless, wearable, and disposable biosensor which can be used to monitor ECG, vital signs, and arrhythmias; a mobile device to relay information from patch to cloud; and a central monitoring interface accessible via internet.