Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up

What this Trial Is About

Researchers are evaluating a remote monitoring approach for patients who have undergone Transcatheter Aortic Valve Implantation (TAVI), focusing on reducing hospital stays and readmissions after the procedure. This trial aims to address common heart rhythm problems that can occur post-TAVI, such as heart block, which sometimes requires pacemaker insertion. The study seeks to improve patient care by using technology to monitor heart function and detect issues early, potentially allowing for same-day discharge. Participants will be randomly assigned to either a remote monitoring group or a standard care group. Those in the remote monitoring group will receive four devices, including a continuous 7-lead ECG patch worn for 72 hours after discharge, and will perform daily 12-lead ECGs along with vital sign recordings for seven days. This group will be supported by a clinical decision algorithm to guide care. The control group will follow the best current standard of care without additional monitoring devices. Throughout the study, participants will be closely monitored for clinical data including ECG changes, vital signs, and adverse events. Researchers will assess outcomes such as hospital length of stay within 30 days, need for pacemaker implantation, emergency visits, hospital admissions, and mortality rates. Anxiety levels will also be measured. The trial includes daily remote consultations when needed, with a follow-up period extending up to three months for some outcomes, aiming to optimize post-TAVI patient management and safety.

Remote Cardiovascular Monitoring in Post-TAVI Patients