Atrial Fibrillation (AF)PAMP FANCT06647914
Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management
An observational study of Atrial Fibrillation (AF), run by IRCCS Policlinico S. Donato.
Trial summary
This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2025to 31 Aug 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients will be recruited at the two Clinical Institution of I.R.C.C.S. Policlinico San Donato and Federico II University of Naples, with the same study protocol approved by the Institutional Board of the respective Institution.
Who may be able to join
- History of paroxysmal or persistent atrial fibrillation
- Clinical indication for Atrial Fibrosis (AF) ablation according to the 2020 ESC Guidelines
Who cannot join
- Age below 18 years old
- Refusal to sign consent
- Noncompliance with the study protocol
Trial locations and contacts
No sites are listed yet.
About this study
This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Harnessing AI, we will extract and correlate hidden components within ECG-obtained P-wave data and echocardiographic studies with atrial fibrosis, culminating in an atrial fibrosis score (AFS). The AFS will non-invasively predict fibrosis extent and AF clinical progression, including metrics like rehospitalization, cardiac morbidity, and mortality. Ultimately, this endeavor aims to improve AF patient management, significantly reducing healthcare costs, and enhancing patient quality of life.
- Conditions
- Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability
The clinical endpoint will be composed by rehospitalization, cardiac morbidity and total mortality data
Measured: Partecipants will be assessed at the baseline and at 6 months and 12 months time points. The AFS Prediction Model Testing will start at 9 months after the beginning of the patients enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start3 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 322 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, Irccs Sdn, Marche Polytechnic university, Ancona, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647914
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12378472
- Acronym
- PAMP FA
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management
- ClinicalTrials.gov ID
- NCT06647914
- Acronym / sponsor ID
- PAMP FA / PNRR-MCNT2-2023-12378472
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Collaborators
- Federico II University, Irccs Sdn, Marche Polytechnic university, Ancona, Italy
- Study start
- 3 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Harnessing AI, we will extract and correlate hidden components within ECG-obtained P-wave data and echocardiographic studies with atrial fibrosis, culminating in an atrial fibrosis score (AFS). The AFS will non-invasively predict fibrosis extent and AF clinical progression, including metrics like rehospitalization, cardiac morbidity, and mortality. Ultimately, this endeavor aims to improve AF patient management, significantly reducing healthcare costs, and enhancing patient quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the two Clinical Institution of I.R.C.C.S. Policlinico San Donato and Federico II University of Naples, with the same study protocol approved by the Institutional Board of the respective Institution.
Key inclusion criteria (2 listed)
- History of paroxysmal or persistent atrial fibrillation
- Clinical indication for Atrial Fibrosis (AF) ablation according to the 2020 ESC Guidelines
Key exclusion criteria (3 listed)
- Age below 18 years old
- Refusal to sign consent
- Noncompliance with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability
Time frame: Partecipants will be assessed at the baseline and at 6 months and 12 months time points. The AFS Prediction Model Testing will start at 9 months after the beginning of the patients enrollment.
The clinical endpoint will be composed by rehospitalization, cardiac morbidity and total mortality data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by IRCCS Policlinico S. Donato.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Pappone, MD, PHD, FACC (+39-0252774260 ext. +390252774260, carlo.pappone@af-ablation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability (time frame: Partecipants will be assessed at the baseline and at 6 months and 12 months time points. The AFS Prediction Model Testing will start at 9 months after the beginning of the patients enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.