Clinical trial NCT06602609: Remote Cardiovascular Monitoring in Post-TAVI Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Cardiac Conduction Disturbance
Digital Health
Transcatheter Aortic Valve Implantation
TAVI
Keywords: POST-TAVI
Hospital Length of Stay
Same-Day Discharge
Remote Monitoring
Ambulatory ECG
Digital Health
Valvular Heart Disease
TAVI
TAVR
Medical Device
Hospital at Home
Home Health
Telemedicine
Virtual Health
ECG
EKG
RCT
Digital Innovation
Technology
Ambulatory
Cardiology
Post-Acute
Post Acute
Digital Technology
Electrocardiogram
Clinical Trials
Telehealth
Home Telemetry
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2024-09-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-centre, prospective, randomised controlled, parallel-group study with open-label randomisation concealment. A total of 216 patients will have a random assignment 1:1 into the active arm (remote monitoring) or control group (standard of care), employing computer-generated randomisation via a minimisation design based on sex and age (75 years ± 8 years).
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative length of stay within 30 days of the procedure.
timeFrame: 30 days
Secondary outcomes:
measure: The difference in rate of new PPM implantation at 3 months.
timeFrame: 3 months
measure: Rate of emergency room visits not requiring admission
timeFrame: 3 months
measure: Number of all hospital admissions at 3 months
timeFrame: 3 months
measure: Mortality Rate at 30 days
timeFrame: 30 days
measure: Patient score for the patient-reported anxiety improvement analysis
timeFrame: at discharge and 30 days
measure: Number of instances of major adverse cardiovascular events
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College London, Imperial College Healthcare NHS Trust
name: Ramzi Khamis, MBChB DIC PhD FESC FRCP
role: PRINCIPAL_INVESTIGATOR
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