Atrial FibrillationPOLICARDIOFANCT05961865
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
An observational study of Atrial Fibrillation and Marker of Inflammation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Marker of Inflammation, Inflammation
- What is being tested?
- Markers of inflammation and fibrosis
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jul 2023to Aug 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Paroxysmal or Persistent Atrial Fibrillation
Who may be able to join
- Paroxysmal or persistent AF;
- Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
- Aged between 18 and 85 years;
- Ability to provide informed consent for study participation.
Who cannot join
- Age > 85 years or < 18 years;
- Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
- NYHA functional class IV;
- Left ventricular ejection fraction <30%;
- Myocardial infarction or unstable angina or recent coronary artery bypass graft (<6 months);
- Significant co-morbidity, such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 12 months;
- Presence of contraindications to the procedure;
- Inability to provide informed consent for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Stefano Carugo, MD, +39 0255033579
About this study
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
Read the detailed description
The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6, N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
- Conditions
- Atrial Fibrillation, Marker of Inflammation, Inflammation, Arrhythmia
- Being tested
- Markers of inflammation and fibrosis
- Medical subject headings
- Atrial Fibrillation, Inflammation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Markers of inflammation and fibrosisDiagnostic test
Will be analyzed the following inflammation markers:
Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).
Measured: One year
Secondary outcomes (2)
Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.
Identify how many AF patients undergoing ablation have a reduction in related symptoms such as shortness of breath, feeling tired and weakness. The patient will answer an EQ-5D-5L questionnaire for symptom assessment
Measured: One year
Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.
Relationship between the degree of inflammation and atrial fibrosis detected through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol) and the degree of atrial fibrosis detected on mapping electroanatomical (voltage map)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start11 Jul 2023
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Stefano Carugo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Stefano Carugo, MD, Principal investigator, IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961865
- Sponsor's protocol ID
- 6672
- Acronym
- POLICARDIOFA
- Status last verified
- Sep 2023
- First submitted
- 9 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05961865
- Acronym / sponsor ID
- POLICARDIOFA / 6672
- Conditions
- Atrial Fibrillation, Marker of Inflammation, Inflammation, Arrhythmia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jul 2023 (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.
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
Detailed description
The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6, N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Paroxysmal or Persistent Atrial Fibrillation
Key inclusion criteria (4 listed)
- Paroxysmal or persistent AF;
- Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
- Aged between 18 and 85 years;
- Ability to provide informed consent for study participation.
Key exclusion criteria (8 listed)
- Age > 85 years or < 18 years;
- Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
- NYHA functional class IV;
- Left ventricular ejection fraction <30%;
- Myocardial infarction or unstable angina or recent coronary artery bypass graft (<6 months);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markers of inflammation and fibrosisWill be analyzed the following inflammation markers: Interleukin 6, N-terminal propeptide of type 1 procollagen (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids. | Diagnostic test | – |
Primary outcome
Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
Time frame: One year
Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).
2 secondary outcomes
Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.
Time frame: One year
Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
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.
Stefano Carugo, MD principal investigator
IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Marker of Inflammation, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Contact Stefano Carugo, MD (+390255033532, stefano.carugo@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment. (time frame: One year). 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 13 Sep 2023.