Remote Cardiovascular Monitoring in Post-TAVI Patients (TELE-TAVI)

February 27, 2026 updated by: Imperial College London

Remote Acute Monitoring-based Same-day Discharge Strategy of Post Transcatheter Aortic Valve Implantation Patients Versus Standard Care at 30-Day Follow-up

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 potential to enhance outcomes and able to predict deterioration following TAVI. Despite the well-characterized high safety and effectiveness profile of TAVI across various surgical risk groups, the adoption of same-day discharge remains limited. Addressing post-TAVI arrhythmias is crucial to minimising the total postprocedural length of stay. Therefore, by embracing a minimalist approach and leveraging the vastly grown operators experience, the current post-TAVI care could be further enhanced with the integration of remote monitoring. This strategic shift aligns with the objective of optimising care by the ability to predict deterioration that can be treated to avoid in-hospital care.

Technology-enabled patient care and monitoring has been steadily improving, and AI-enabled remote patient monitoring devices has brought a crucial advantage to an outside-of-hospital cardiac investigation. The potential to remotely detect any adverse effects that patients might develop after the procedure is promising. There is an increased uptake of ECG telemetry, which might serve as a valuable tool that may significantly reduce hospital LOS at 30 days and possibly could reduce 3 months' adverse outcomes. This approach may enhance patient care and optimise post-TAVI outcomes through an efficient patient-tailored approach. Several studies have utilised remote or ambulatory ECG for post-TAVI on different clinical outcomes - however, to date, no RCT has been conducted using this approach. The findings of remote ECG monitoring studies are inconsistent with various monitoring periods and patient selection criteria. Although such studies utilised ECG monitoring, they did not integrate a strategy or pathway for out-of-hospital monitoring and clinical decision algorithms during home monitoring. To date, the TELE-TAVI trial will be the first monitoring study to incorporate live event detection and alert notification system supported by the bespoke Smartcardia 7-lead continuous ECG patch monitor in an RCT.

In order to better understand the impact of remote patient monitoring after TAVI, this trial proposes the utilisation of a remote monitoring algorithm to provide essential clinical data for guiding management, with the primary aim of reducing postprocedural hospital length of stay and readmissions. This strategic technology integration aims to address the gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care.

Thus, it has been hypothesised that:

  1. A remote patient monitoring protocol-driven strategy for same-day discharge, post-TAVI, is superior to the current standard of care follow-up in reducing cumulative 30-day hospital length of stay (LOS).
  2. The novel remote patient monitoring strategy, supported by a clinical decisions algorithm, is more effective at prioritising patient presentations and optimising outcomes through early identification of adverse events, such as the need for a pacemaker, when compared to the standard of care.

The principal aims of this clinical randomised trial are:

  • To facilitate a safe same-day discharge after TAVI through a remote monitoring approach in order to reduce postprocedural hospitalisation.
  • To integrate an algorithm-based clinical decision-making protocol that enhances remote monitoring and the detection of post-TAVI adverse events, particularly focusing on cardiac conduction complications.
  • To test the effectiveness of the remote monitoring strategy in the cost-effectiveness of post-TAVI patients' hospital admission and re-admission.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0NN
        • Recruiting
        • Hammersmith Hospital
        • Principal Investigator:
          • Adam Hartley, MBChB PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
The control group adheres to the best standard of care as per current practice.
Other: Standard Medical Therapy
No intervention is required. Patients in this arm will fill out a self-reported anxiety report (SHAI form) and provide recent admission information
Other Names:
  • Current standard of care
Active Comparator: Remote Monitoring Group
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.
Other: Remote Patient Monitoring Strategy
Continuous remote monitoring with the SmartCardia device includes continuous heart rate and cardiac conduction rhythm tracking through a 7-lead ECG enhanced by machine learning. This system can detect cardiac rhythm disturbances, measure breathing and heart rate, and provide live-alert notifications. Daily 12-lead ECG will be collected from each patient for 7 days after discharge; patients are instructed to perform a daily 12-lead ECG on the SHL device, along with recording blood pressure and oxygen saturation levels. Each ECG is interpreted by the trial team, and a cardiologist's interpretation is confirmed, and patients will undergo remote consultations with a cardiologist or research nurse each day if needed. During the initial 30 days of patient recruitment, if the individual exhibits potential cardiac symptoms, they can activate a remote consultation by performing an extra 12-lead ECG and recording blood pressure and oxygen saturation levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative length of stay within 30 days of the procedure.
Time Frame: 30 days
Post-procedural hospital length of stay will be compared between study groups
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in rate of new PPM implantation at 3 months.
Time Frame: 3 months
Difference between intervention to control groups
3 months
Rate of emergency room visits not requiring admission
Time Frame: 3 months
Accident and Emergency (A&E) visits, advised by research team and unadvised
3 months
Number of all hospital admissions at 3 months
Time Frame: 3 months
Planned admissions instigated by the research team vs. unplanned
3 months
Mortality Rate at 30 days
Time Frame: 30 days
Mortality rate will be compared in both study groups
30 days
Patient score for the patient-reported anxiety improvement analysis
Time Frame: at discharge and 30 days
Patients in both study groups will fill out the questionnaire SHAI (Short Health Anxiety Inventory) score range 3 to 38 where 38 means lower anxiety.
at discharge and 30 days
Number of instances of major adverse cardiovascular events
Time Frame: 3 months
Major adverse cardiovascular events in this study were recognised as myocardial infarction, cerebral vascular accident (CVA), and cardiovascular-related death.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

King Khalid University

Investigators

  • Principal Investigator: Ramzi Khamis, MBChB DIC PhD FESC FRCP, Imperial College London, Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24HH8773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Once the study is complete and analysed, whilst individual patient results will not be disclosed, the overall research findings may be submitted for publication in a scientific journal and presented at scientific conferences following the completion of the study. A summary of the research findings will be uploaded onto the Imperial College London website. All data will be anonymised and kept confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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