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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT04845750
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years and legal capacity.
* Atrial fibrillation, diagnosed in accordance with the guidelines of the ESC (version 2016) - permanent AF excluded.
* Patient planned for a pulmonary vein isolation catheter ablation procedure using cryoenergy and suitable for treatment according to the respective instructions for use (IFU).
* Signed and dated informed consent documented by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrolment (patient has received a copy of the ICF).
Exclusion Criteria:
* Indication that the vascular system is not accessible through the left or right groin.
* Indication that a transseptal puncture cannot be performed.
* Any previous ablation or surgery due to AF.
* Important comorbidities such as cardiovascular events within six months of enrolment or high-risk surgical patients.
* Left atrial diameter \> 50 mm in the short axis.
* Advanced structural heart disease including
* moderate-to-severe valvular stenosis or regurgitation,
* previous valve replacement or valve repair,
* congenital heart disease,
* left ventricular ejection fraction \< 45% during sinus rhythm,
* congestive heart failure NYHA III or IV,
* coronary artery bypass graft surgery within the last 3 months.
* Permanent pacemaker.
* Pregnant women at the time of the cryoablation procedure.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent Form.
* Participation in interventional trials for cardiovascular devices or drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04845750
Study Brief:
Protocol Section:
NCT04845750