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:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT04342832
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18-80;
* HF with ejection fraction \<40%, as assessed by recent (\<6 months) echocardiography or cardiovascular magnetic resonance imaging (CMR);
* AF, documented on standard ECG or Holter monitoring;
* Eligible for both treatment arms;
* Signed and dated informed consent prior to admission to the trial.
Exclusion Criteria:
* End-stage heart failure: NYHA class IV, patients on waiting list for cardiac transplant and/or left ventricular assist device;
* Long-standing (\> 1 year) persistent or permanent AF;
* Previous pulmonary vein isolation or surgical ablation;
* Left atrial diameter ≥60 mm or left atrial volume index ≥50 ml/m2;
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) ≤25 ml/min/1.73m2;
* Recent (\<90 days) acute coronary syndrome, cardiac intervention1, or stroke/transient ischemic attack (TIA);
* Planned or expected cardiac surgery in the following year;
* Active infectious disease or malignancy;
* Women who are pregnant or planning to become pregnant during the trial;
* Contraindication for cryoballoon ablation or other condition that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04342832
Study Brief:
Protocol Section:
NCT04342832