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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient age must be 18 years or above.

• Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care:

• Vascular: Controlled with adequate vascular hemostasis.

• Neurological: Conscious and oriented, not under the effect of residual sedation.

• Cardiac: No significant pericardial effusion.

• Elective non-emergent patient admission and nonelective cases fitting discharge criteria.

• Comfortable ambulation post-procedure.

• The patient or their caregiver must have access to a smart device.

• Ability to provide informed consent (the patient must be alert and oriented for consent).

• Adequate social support.

Locations
Other Locations
United Kingdom
Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Badr Alharbi, BScEMS, MSc
b.al-harbi23@imperial.ac.uk
+44(0)7771429219
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 216
Treatments
Other: Control Group
The control group adheres to the best standard of care as per current practice.
Active_comparator: Remote Monitoring Group
Those in the remote monitoring group will be given four devices, which will help the research team make decisions about their health condition based on the data collected. The active arm group will wear the continuous ECG device for 72 hours from discharge and will be instructed to acquire a daily 12-lead ECG and record vital signs until day 7 of hospital discharge. Additionally, participants will utilise 12-lead ECG and vital signs will be measured only when experiencing symptoms.
Sponsors
Leads: Imperial College London
Collaborators: King Khalid University

This content was sourced from clinicaltrials.gov