Status:
RECRUITING
Remote Cardiovascular Monitoring in Post-TAVI Patients
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
King Khalid University
Conditions:
Aortic Valve Stenosis
Cardiac Conduction Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Given the susceptibility of post-TAVI patients to bradyarrhythmias and extended hospitalisation is not economically plausible, a shift toward remote monitoring could be both justifiable and has the po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06602609
Start Date
September 11 2024
End Date
July 1 2028
Last Update
September 19 2024
Active Locations (1)
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1
Hammersmith Hospital
London, United Kingdom, W12 0NN