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NCT Number: NCT06449079

The PICM Risk Prediction Study - Application of AI to Pacing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys' and St Thomas' Hospital NHS Trust, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Machine learning

Other

Analysis of data with machine learning methods

Primary outcomes

  1. Primary aim

    Time frame: 2.5 years

    Number of risk factors in participants who developed pacing induced cardiomyopathy

Secondary outcomes

  1. Secondary aim

    Time frame: 2.5 years

    • To establish, through the GSTT/RBH/KCH/ICH RV-paced study population the prevalence of pacemaker induced cardiomyopathy (PICM)
  2. Tertiary aim

    Time frame: 2.5 years

    • 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
  3. Quarternary aim

    Time frame: 2.5 years

    3.• To establish mortality of PICM

  4. Quinary aim

    Time frame: 2.5 years

    • To establish the morbidity of PICM
  5. Senary aims

    Time frame: 2.5 years

    5.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of right ventricular lead position or leadless pacemaker position

  6. Septenary aim

    Time frame: 2.5 years

    6.• To include predictive value for pacing induced cardiomyopathy risk with combination of imaging data of myocardial pathology from echocardiogram and cardiac MRI

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • Imperial College Healthcare NHS Trust
  • King's College Hospital NHS Trust

Registry information

Official study title

Predictive Risk Algorithm for Development of Right Ventricular Pacing Induced Cardiomyopathy - a Step Towards Personalized Pacemaker Lead Deployment

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2024
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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