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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05006456
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older
* Signed informed consent to participate in the study
* Drug refractory symptomatic paroxysmal AF or symptomatic persistent AF for less than 12 months who, in the opinion of the investigator, are candidates for catheter ablation per standard-of-care
* Undergoing AF ablation for the first time
* THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT or newer technologies (e.g. QDOT, HELIOSTAR) are used in conjunction with Carto system in the ablation procedure
Exclusion Criteria:
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study
* The subject has a life expectancy of less than 12 months
* Severe valvular heart disease
* The subject has been enrolled in another investigational study evaluating a medical device or a drug.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05006456
Study Brief:
Protocol Section:
NCT05006456