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Heart FailureNCT06449079

The PICM Risk Prediction Study - Application of AI to Pacing

An observational study of Heart Failure and Pacemaker-Induced Cardiomyopathy, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Machine learning
How many people
10,000 participants
Where
3 sitesUnited Kingdom
Study dates
30 Jul 2024to 30 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients who received a pacemaker at GSTT and RBH in the last 10 years and all patients who received a pacemaker at KCH and ICH in the last 3 years.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom3 sites

  • Guys' and St Thomas' Hospital NHS Trust

    London, SE1 7EH

    Aldo Rinaldi, MD, MBBS, FRCP, FHRS, aldo.rinaldi@gstt.nhs.uk

    Sandra Howell, MBBS, MSc, MSc, sandra.howell@gstt.nhs.uk

  • Kings' College London Healthcare Trust

    London, SE5 9RS

    Francis Murgatroyd, francis.murgatroyd@nhs.net

  • Imperial College London Healthcare Trust

    London, W12 0HS

    Steven Niederer, MPhil, PhD, s.niederer@imperial.ac.uk

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
Machine learning
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Machine learningOther

    Analysis of data with machine learning methods

Study groups in NCT06449079
Study groupRoleWhat they receive
Pacing induced cardiomyopathyPatients who received a pacing device and developed pacing induced cardiomyopathy
Receives: Other: Machine learning
Non-pacing induced cardiomyopathyPatients who received a pacing device and did not develop pacing induced cardiomyopathy
Receives: Other: Machine learning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary aim

    Number of risk factors in participants who developed pacing induced cardiomyopathy

    Measured: 2.5 years

Secondary outcomes (6)

  1. Secondary aim

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

    Measured: 2.5 years

  2. Tertiary aim

    1. 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

    Measured: 2.5 years

  3. Quarternary aim

    3.• To establish mortality of PICM

    Measured: 2.5 years

  4. Quinary aim

    1. To establish the morbidity of PICM

    Measured: 2.5 years

  5. 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

    Measured: 2.5 years

  6. 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

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2024
  2. Study start30 Jul 2024 (estimated)
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06449079
Sponsor's protocol ID
333705
Status last verified
Jun 2024
First submitted
25 Mar 2024
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Pacemaker-Induced Cardiomyopathy, run by Guy's and St Thomas' NHS Foundation Trust at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary aim (time frame: 2.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06449079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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