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Remote Cardiovascular Monitoring in Post-TAVI Patients

RecruitingNAAges 18 Years - anyAllImperial College London
NCT06602609 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Remote Patient Monitoring Strategy
  • Standard Medical Therapy
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Where

1 site
Hammersmith Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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