Actively Recruiting
Remote Cardiovascular Monitoring in Post-TAVI Patients
Led by Imperial College London · Updated on 2026-03-03
216
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
K
King Khalid University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remote Cardiovascular Monitoring in Post-TAVI Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age must be 18 years or above.
- Post-TAVI patients without serious complications requiring inpatient care, including controlled vascular issues with adequate hemostasis.
- Neurologically conscious and oriented patients not affected by residual sedation.
- No significant pericardial effusion.
- Elective non-emergent admission or nonelective cases meeting discharge criteria.
- Comfortable ambulation after the procedure.
- Patient or caregiver must have access to a smart device.
- Ability to provide informed consent with alertness and orientation.
- Adequate social support.
You will not qualify if you...
- Hemodynamically unstable after TAVI, including cardiac arrest, stroke, acute kidney injury, or major bleeding requiring transfusion.
- Presence of a permanent implanted pacemaker device.
- Procedural failure in device delivery.
- Major vascular access complications requiring hospital stay.
- Inability to use the required technology.
- Significant communication barriers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hammersmith Hospital
London, United Kingdom, W12 0NN
Actively Recruiting
Research Team
B
Badr Al Harbi, BScEMS, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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