Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602609
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Remote Cardiovascular Monitoring in Post-TAVI Patients
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-TAVI
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None