Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06602609

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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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