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NCT05961865Recruiting

Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 13 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
9 Jul 2023
Start date
11 Jul 2023
Primary completion date
Jul 2027
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
NCT number
NCT05961865

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 11 Jul 2023 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Lab values

  • Left ventricular ejection fraction \<30%;

Age

  • Age \> 85 years or \< 18 years;

Other

  • NYHA functional class IV;
  • Presence of contraindications to the procedure;
  • Inability to provide informed consent for study participation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.