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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT04678258
Eligibility Criteria:
Inclusion Criteria:
* Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG
* Given class I indication for curative CTI ablation according to the current guidelines
* Over 18 years old
* Given informed consent
Exclusion Criteria:
* Any contraindication for CTI ablation
* Previous CTI ablation
* BCB as procedural endpoint not assessable
* CTI ablation conducted in association with further ablation procedures
* Patients with CIED (e.g. pacemaker, ICD)
* Tricuspid valve replacement
* Right atrial thrombus
* Pregnant or breastfeeding women
* Abuse of drugs or alcohol
* Age \< 18 years
* Incompliance to the treatment, e.g. necessary anticoagulation
* Expected survival less than one year
* Inability to understand the nature and rationale of the study
* Inability to take part in the follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04678258
Study Brief:
Protocol Section:
NCT04678258