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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT03263702
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age.
* Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
* Ability to understand the requirements of the study and sign the informed consent form.
* Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
* Projected lifespan greater than 1 year.
Exclusion Criteria:
* They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
* Rheumatic heart disease
* Current intra-cardiac thrombus
* History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
* Unstable angina
* CVA or TIA within 3 months
* Contraindication to anticoagulation
* Class IV HF
* Unable to sign consent
* Projected lifespan of \< 1 year
* Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
* Participation in another study that would interfere with this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03263702
Study Brief:
Protocol Section:
NCT03263702