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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT04906668
Eligibility Criteria:
Inclusion Criteria:
* Persistent AF according to current ESC guideline (2020)
* Symptoms EHRA classification II - IV despite guideline indicated medical therapy
* Age ≥ 75 years
* Capability of giving written informed consent
Exclusion Criteria:
* impaired systolic left ventricular function (ejection fraction \< 50%)
* High-grade (III°) left cardiac valvular disease
* pre-implanted pacemaker
* bradycardia-indication for pacemaker
* Surgical coronary revascularization (within the last 90 days) or current triple therapy after stent PCI
* contraindication for PVI or pacemaker-implantation
* contraindication for oral anticoagulation
* body-mass-index BMI \> 40 kg/m2
* inability to give written informed consent
* concomitant participation in another registered trial
* life expectancy \< 12 months
* reversible cause of AF (e.g. thyrotoxicosis, alcohol ingestion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Maximum Age:
99 Years
Study:
NCT04906668
Study Brief:
Protocol Section:
NCT04906668