Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
Recruiting · NCT05961865 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
View the official record on ClinicalTrials.gov →Interventions studied
Markers of inflammation and fibrosis
What this trial is about
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
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico - Milan, Italy