Remote monitoring for patients after heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to implement a remote monitoring algorithm to collect vital clinical data for patients who have undergone Transcatheter Aortic Valve Implantation (TAVI). By utilizing technology, the study seeks to reduce hospital length of stay and readmissions by addressing potential heart conduction issues that may arise post-procedure. Eligible patients will be monitored remotely to predict and manage any complications, allowing for same-day discharge when appropriate. The trial will assess whether this approach can effectively enhance patient care and outcomes following TAVI.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hammersmith Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Ramzi Khamis, MBChB DIC PhD FESC FRCP — Imperial College London, Imperial College Healthcare NHS Trust
• Study coordinator: Badr Al Harbi, BScEMS, MSc
• Email: b.al-harbi23@imperial.ac.uk
• Phone: +44(0)7771429219

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.