Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06184633
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -
* Age ≥ 18
* Obesity, as defined as:
* BMI ≥ 30 kg/m2, or
* BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)
* Scheduled ECV
* Written informed consent
Exclusion Criteria:
* Permanent AF
* Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery
* Current or previous treatment with amiodaron
* HbA1c ≥ 48 mmol/L, \<3 months prior to randomization
* History of diabetes mellitus type 1 or 2
* Prior bariatric surgery
* Use of other anti-obesity medication, \<3 months prior to enrollment
* Contra-indication for, or prior use of a GLP1-receptor agonist
* History of chronic pancreatitis or acute pancreatitis \<6 months
* Acute coronary syndrome \<6 months
* Severe (grade III) valvular disease
* eGFR \<30 mL/min/1.73m2
* Heart failure NYHA class III-IV
* Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
* Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy \<12 months, as judged by the treating physician.
* Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06184633
Study Brief:
Protocol Section:
NCT06184633