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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06449079
Other study ID # 333705
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 30, 2024
Est. completion date October 30, 2026

Study information

Verified date June 2024
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date October 30, 2026
Est. primary completion date October 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients who received a pacing device (VVI, DDD, ICD, leadless pacemaker) from the GSTT/RBH/KCH/ICH database in the last 10 years (from 01/01/2014) - All patients who are >18 years old. - Male and Female Exclusion Criteria: - Patients who did not receive a pacing device (VVI, DDD, ICD, leadless pacemaker) - All patients <18 years old - Patients with congenital heart disease - Patients who have received artificial heart valves or underwent cardiac bypass surgery - Patients who did not have an echocardiogram after receiving a pacing device

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Machine learning
Analysis of data with machine learning methods

Locations

Country Name City State
United Kingdom Guys' and St Thomas' Hospital NHS Trust London
United Kingdom Imperial College London Healthcare Trust London
United Kingdom Kings' College London Healthcare Trust London

Sponsors (3)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust Imperial College Healthcare NHS Trust, King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary aim Number of risk factors in participants who developed pacing induced cardiomyopathy 2.5 years
Secondary Secondary aim 1. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the prevalence of pacemaker induced cardiomyopathy (PICM) 2.5 years
Secondary Tertiary aim 2. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the incidence of PCIM 2. To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the incidence of PCIM 2.5 years
Secondary Quarternary aim 3.• To establish mortality of PICM 2.5 years
Secondary Quinary aim 4. To establish the morbidity of PICM 2.5 years
Secondary Senary aims 5.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of right ventricular lead position or leadless pacemaker position 2.5 years
Secondary Septenary aim 6.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of myocardial pathology from echocardiogram and cardiac MRI 2.5 years
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