The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay.
The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care).
Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management.
Participants in the control group will: adhere to the best standard of care as per current practice.
Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.
Patient age must be 18 years or above.
Vascular: Controlled with adequate vascular hemostasis.
Neurological: Conscious and oriented, not under the effect of residual sedation.
Cardiac: No significant pericardial effusion.
Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion.
Patients with a permanent (pre-existing or new) implanted pacing device.
Procedural failure in device delivery.
Major vascular access complications require patients to stay.
Parallel
Remote Patient Monitoring Strategy
Other interventionContinuous remote monitoring with the SmartCardia device includes continuous heart rate and cardiac conduction rhythm tracking through a 7-lead ECG enhanced by machine learning. This system can detect cardiac rhythm disturbances, measure breathing and heart rate, and provide live-alert notifications. Daily 12-lead ECG will be collected from each patient for 7 days after discharge; patients are instructed to perform a daily 12-lead ECG on the SHL device, along with recording blood pressure and oxygen saturation levels. Each ECG is interpreted by the trial team, and a cardiologist's interpretation is confirmed, and patients will undergo remote consultations with a cardiologist or research nurse each day if needed. During the initial 30 days of patient recruitment, if the individual exhibits potential cardiac symptoms, they can activate a remote consultation by performing an extra 12-lead ECG and recording blood pressure and oxygen saturation levels.
Standard Medical Therapy
Other interventionNo intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information
Cumulative length of stay within 30 days of the procedure.
Post-procedural hospital length of stay will be compared between study groups
The difference in rate of new PPM implantation at 3 months.
Difference between intervention to control groups
Rate of emergency room visits not requiring admission
Accident and Emergency (A\&E) visits, advised by research team and unadvised
Number of all hospital admissions at 3 months
Planned admissions instigated by the research team vs. unplanned
Mortality Rate at 30 days
Mortality rate will be compared in both study groups
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Imperial College London
Lead sponsor
King Khalid University
Collaborator
