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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT05881733
Eligibility Criteria:
Inclusion Criteria:
1. History of symptomatic paroxysmal AF
2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF
3. Subjects who are willing and capable of providing informed consent
4. Subjects who are willing and capable of participating in all testing associated with this clinical investigation
5. Subjects whose age is 18 years or above
Exclusion Criteria:
1. Any known contraindication to an AF ablation or anticoagulation
2. History of previous left atrial ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia
3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause
4. Significant structural heart disease as evidenced by:
1. Left ventricular ejection fraction \<45% based on most recent transthoracic echocardiogram (TTE) performed \<6 months prior to enrollment
2. LA diameter \>55 mm based on most recent TTE performed \<6 months prior to enrollment
3. Previous cardiac surgery
4. Previous cardiac valvular surgical or percutaneous procedure
5. Interatrial baffle, closure device, patch, or occluder
6. Unstable angina or ongoing myocardial ischemia
7. Moderate or severe valvular heart disease on most recent TTE performed \<6 months prior to enrolment
8. Congenital heart disease
9. Left atrial thrombus
5. History of blood clotting or bleeding disease
6. Stroke or transient ischemic attack \<3 months prior to enrollment
7. Active systemic infection
8. Common ostium PV \>24 mm defined by CT-scan
9. Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study
10. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05881733
Study Brief:
Protocol Section:
NCT05881733