Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449079
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-25
Brief Title:
The PICM Risk Prediction Study - Application of AI to Pacing
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Predictive Risk Algorithm for Development of Right Ventricular Pacing Induced Cardiomyopathy - a Step Towards Personalized Pacemaker Lead Deployment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Development of pacing induced cardiomyopathy PICM is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality At present a lack of data leads to a failure to identify patients who are at risk of PICM and would benefit from pre-selection to physiological pacing In the light of the foregoing there is an urgent need for novel non-invasive detection techniques which would aid risk stratification offer a better understanding of the prevalence and incidence of PICM in individuals with pacing devices and the contribution of additional risk factors
Detailed Description:
Retrospective review of patient characteristics including 12 lead resting electrocardiograms and imaging data CMR CT echo CXR and fluoroscopy of pacing leads of patients with right sided ventricular pacing lead due to symptomatic bradycardia who developed pacing induced cardiomyopathy or need for CRT upgrade versus patients who did not using supervised machine learning methods Development of personalised predictive pacing algorithm to improve right ventricular lead placement such as conduction system pacing or pre-emptive implantation of an additional left ventricular lead to prevent left ventricular dilatation and pacemaker-induced cardiomyopathy PICM with heart failure left ventricular ejection fraction 50 by Simpson method hospitalisation or death with the use of the retrospective patient data through machine learning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None