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Remote Cardiovascular Monitoring in Post-TAVI Patients

Key facts

Who runs it
Imperial College London
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
216 people, planned
Started
1 Nov 2024
Expected to end
1 Jul 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Remote Patient Monitoring Strategy
  • Standard Medical Therapy
Record updated
3 March 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion
  • Procedural failure in device delivery
  • Patients with a permanent (pre-existing or new) implanted pacing device
  • Major vascular access complications require patients to stay
  • Inability to engage with the technology
  • Significant communication barrier

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Control GroupOther group

    The control group adheres to the best standard of care as per current practice.

    Treatment: Standard Medical Therapy

  • Remote Monitoring GroupExisting treatment, for comparison

    Those in the remote monitoring group will be given four devices, which will help the research team make decisions about their health condition based on the data collected. The active arm group will wear the continuous ECG device for 72 hours from discharge and will be instructed to acquire a daily 12-lead ECG and record vital signs until day 7 of hospital discharge. Additionally, participants will utilise 12-lead ECG and vital signs will be measured only when experiencing symptoms.

    Treatment: Remote Patient Monitoring Strategy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up
Record updated
3 March 2026