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 @ 12:46 PM
Ignite Modification Date:
2025-12-24 @ 12:46 PM
NCT ID:
NCT03906461
Eligibility Criteria:
Inclusion Criteria:
1. Subject must provide written informed consent prior to any clinical investigation related procedure.
2. Subject is at least 18 years of age.
3. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
5. Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.
* For the purposes of this study, "intolerant" includes either:
1. Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
2. Subject was offered the drug and refused to take for any reason.
Exclusion Criteria:
1. Previous ablation or surgery in the left atria.
2. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
3. Participation in another clinical investigation that may confound the results of this study.
4. Pregnant or nursing.
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Life expectancy less than 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03906461
Study Brief:
Protocol Section:
NCT03906461