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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03242694
Eligibility Criteria:
Inclusion Criteria:
* documented, symptomatic persistent atrial fibrillation (AF)
* catheter ablation is indicated
* aged 18-75 years
* signed Patient Informed Consent Form
* able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
* secondary AF
* paroxysmal, long-standing persistent or permanent AF
* ejection fraction \< 30%
* GFR \<30 ml/min/1.73m2
* unstable angina pectoris or myocardial infarction within the past 2 months
* severe heart failure (NYHA IV)
* severe COPD (GOLD III-IV)
* previous left atrial catheter ablation
* previous transthoracic cardiac surgery
* implanted cardiac device (pacemaker, ICD, CRT, VAD)
* awaiting cardiac transplantation or other cardiac surgery within the next 12 months
* any contraindication for pulmonary vein isolation, MRI or anticoagulation
* coagulopathy
* active malignancy, left atrial myxoma
* autoimmune disorder, chronic inflammatory disease
* acute illness, active systemic infection, sepsis
* women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months
* aged under 18 years or above 75 years
* enrollment in other studies, which exclude participation in other studies
* patient not willing or not able to sign the informed consent form
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03242694
Study Brief:
Protocol Section:
NCT03242694