Remote Cardiovascular Monitoring in Post-TAVI Patients
Launched by IMPERIAL COLLEGE LONDON · Sep 17, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how effective remote monitoring can be for patients who have recently undergone a procedure called Transcatheter Aortic Valve Implantation (TAVI). TAVI is a treatment for a heart condition where the aortic valve is narrowed, making it hard for the heart to pump blood. After this procedure, some patients may experience issues with their heart's electrical signals, which can lead to complications. The trial aims to see if using special remote monitoring devices and a smart algorithm to track patients' health can help reduce the time they need to stay in the hospital and lower the chances of returning to the hospital after discharge.
To participate in the trial, you need to be at least 18 years old and have had a TAVI without serious complications that would keep you in the hospital. You'll also need to be able to walk comfortably after the procedure and have access to a smart device, like a smartphone or tablet. If you join the study, you may receive remote monitoring devices that help track your heart health, or you may receive standard care without those devices. The goal is to find out if this new way of monitoring can improve recovery and help patients feel better after their TAVI procedure.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
- • Inability to engage with the technology.
- • Significant communication barrier.
About Imperial College London
Imperial College London is a world-renowned research institution based in the United Kingdom, recognized for its commitment to advancing medical science and improving patient care through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, Imperial combines expertise across various fields, including medicine, engineering, and business, to drive breakthroughs in healthcare. The institution’s robust clinical trial programs are designed to evaluate new therapies and interventions, ensuring rigorous scientific standards and ethical practices while aiming to translate research findings into tangible benefits for patients and society.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Patients applied
Trial Officials
Ramzi Khamis, MBChB DIC PhD FESC FRCP
Principal Investigator
Imperial College London, Imperial College Healthcare NHS Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported