News | Wearables | September 25, 2020

VitalConnect Announces Initiation of TELESTAR-TAVR Clinical Study

Study will evaluate the impact of remote patient monitoring on clinical outcomes, readmission rates, and patient satisfaction following a transcatheter aortic valve replacement procedure

The VitalPatch RTM biosensor is being used in the TELESTAR-TAVR clinical study (Deployment of Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients). It 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 VitalPatch RTM biosensor is being used in the TELESTAR-TAVR clinical study to evaluate patients who undergo a transcatheter aortic valve replacement (TAVR) and monitor them following the procedure utilizing the latest technology from VitalConnect, VistaSolution LIVE. 

September 25, 2020 — Remote and in-hospital wearable biosensor technology company VitalConnect Inc. has started the TELESTAR-TAVR clinical study (Deployment of Telemedicine for Symptom Tracking And Decrease Readmission Rate in TAVR Patients). It 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.

“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 M.D., 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, 14 and 21 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 three components:

   1. VitalPatch RTM: a wireless, wearable, and disposable biosensor which can be used to monitor ECG, vital signs, and 19 arrhythmias;

   2. VistaTablet: mobile device to relay information from patch to cloud; and 3) VistaCenter: a central monitoring interface accessible via internet.

Founded in 2011, VitalConnect has deployed more than 100,000 VitalPatches across the world, including care facilities such as Hackensack Medical Center, Northwell Health, and John Radcliffe Hospital-Oxford University. The VitalPatch allows real-time remote or in-hospital monitoring, cardiac monitoring and a solution for monitoring patients with COVID-19, allowing physicians to monitor patients without necessarily taking up bed space needed for patients with more immediate needs and limiting exposure for patients and staff.

For more information: www.vitalconnect.com

 

Related TAVR and Wearable Content:

VIDEO: Use of a Temporary Pacing Lead in TAVR

Key TAVR Takeaways From ACC 2020

U.S. TAVR Outcomes Need Improvement Based on TVT Registry Analysis

VIDEO: TAVR Performs as Well as Surgery in Low-Risk Patients

VIDEO: Overview of the TAVR Program at Tufts Medical Center — Interview with Andrew Weintraub, M.D.

VIDEO: The Expansion of TAVR Following the FDA Clearing its Use in All Patients — Interview with Torsten Vahl, M.D.

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