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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT06729866
Eligibility Criteria:
Inclusion Criteria:
1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent
2. ECG-documented episode of persistent AF lasting longer than 7 days
3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
2. Patients who are ≥ 18 years
3. Patient participation requirements:
1. Is willing and capable of providing Informed Consent to undergo study procedures
2. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Exclusion Criteria:
1. AF that is:
1. Paroxysmal (longest AF episode \< 7days)
2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
3. Any of the following cardiac conditions:
1. Clinically significant arrhythmias other than AF, AFL or AT
2. NYHA Class IV CHF
3. Atrial or ventricular septal defect closure
4. Atrial myxoma
5. History of congenital heart disease with any residual anatomic or conduction abnormality
4. Any of the following within 3 months of enrollment:
1. Myocardial infarction
2. Unstable angina
3. Percutaneous coronary intervention
4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
5. Heart failure hospitalization
6. Stroke or TIA
7. Clinically significant bleeding
8. Pericarditis or pericardial effusion
9. Left atrial thrombus
5. History of blood clotting or bleeding abnormalities.
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Sensitivity to contrast media not controlled by premedication
8. Women of childbearing potential who are pregnant, lactating or not using birth control
9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to
1. Body mass index (BMI) \> 40 transplant
2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
3. Renal insufficiency with an estimated creatinine clearance \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
4. Active malignancy or history of treated cancer within 24 months of enrollment
5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
6. Clinically significant infection
7. Predicted life expectancy less than one year
10. Current or anticipated enrollment in any other clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06729866
Study Brief:
Protocol Section:
NCT06729866