Evaluating inflammation changes in patients after heart rhythm procedure
Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
This study looks at how inflammation and fat levels change in people aged 18 to 85 after they have a heart procedure to treat atrial fibrillation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05961865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between inflammation markers and local fat levels in patients undergoing catheter ablation for atrial fibrillation. It will analyze various inflammation and fibrosis markers, including Interleukin 6 and tumor necrosis factor, at different time points before and after the procedure. The study will include patients aged 18 to 85 who meet specific clinical criteria and can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with paroxysmal or persistent atrial fibrillation scheduled for catheter ablation.
Not a fit: Patients over 85 years old, those with severe comorbidities, or contraindications to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of inflammation's role in atrial fibrillation and improve patient outcomes post-ablation.
How similar studies have performed: Other studies have explored inflammation in relation to atrial fibrillation, suggesting potential for meaningful insights, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Milan
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Carugo, MD — IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico
- Study coordinator: Stefano Carugo, MD
- Email: stefano.carugo@policlinico.mi.it
- Phone: +390255033532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.