Measuring Inflammation Markers in Patients Having Heart Rhythm Ablation
Studies inflammation markers and fat around the heart in adults with atrial fibrillation.
Key facts
- Who runs it
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Where
- Milan, ItalySee the site
- Trial code
- Registry title
- Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
- Status
- Recruiting
- People taking part
- 180 people, planned
- Started
- 11 Jul 2023
- Expected to end
- Aug 2027
- Type of study
- Observational
- Treatments tested
- Markers of inflammation and fibrosis
- Record updated
- 13 September 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with paroxysmal or persistent atrial fibrillation who are having a catheter ablation. It studies inflammation markers before and after the procedure.
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- Paroxysmal or persistent atrial fibrillation (AF), having a catheter ablation procedure approved by the ESC/ERAH
Main reasons for not taking part
- Blood clot in the left atrial appendage on the scan before the procedure
- NYHA functional class IV
- Left ventricular ejection fraction below 30%
- Heart attack, unstable angina or recent bypass surgery (less than 6 months ago)
- Serious illness such as cancer, severe kidney failure needing dialysis, severe lung disease or cirrhosis, with a life expectancy of less than 12 months
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 take part
- Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram
- 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
- Left ventricular ejection fraction <30%
- Age > 85 years or < 18 years
- NYHA functional class IV
- Presence of contraindications to the procedure
- Inability to provide informed consent for study participation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in Italy
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyContact: Stefano Carugo, MDTaking people
About the trial
What the trial wants to find out
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
Treatments tested
- Markers of inflammation and fibrosis
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
- Plain-language title
- Measuring Inflammation Markers in Patients Having Heart Rhythm AblationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05961865, who can take part
- Record updated
- 13 September 2023