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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT01570361
Eligibility Criteria:
Inclusion Criteria:
1. Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
2. HATCH Score of at least ≥1 and ≤4.
3. Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
4. Age 60 years or older.
5. Left atrium (LA) diameter ≤ 55mm by TTE.
6. Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.
NOTE: For patients entering the study in AF with an ejection fraction ≥35% and \<50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is \>50% the subject can continue in the study.
7. Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.
Exclusion Criteria:
1. Patients awaiting cardiac transplantation or other cardiac surgery.
2. Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
3. Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
4. Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
5. Heart failure decompensation.
6. Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.
7. Previously required cardioversion \>48 hours after onset of atrial fibrillation/ atrial flutter.
8. Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.
9. Pulmonary embolism or recent atrial embolism/thrombosis.
10. Hypertrophic obstructive cardiomyopathy.
11. Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).
12. Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.
13. Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
14. Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.
15. Prior AV nodal ablation.
16. Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
17. Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
18. Medical conditions limiting expected survival to \<3 years.
19. Concurrent participation in any other clinical study.
20. Prior history of non-adherence to prescribed drug regimens.
21. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial
NOTE: Prior ablation of the cavo-tricuspid isthmus is not a reason to exclude, if the patient develops subsequent recurrent atrial fibrillation.
NOTE: For patients randomized to the PVI group (Test Group), a Transesophageal Echocardiography (TEE) should be performed (as per standard of care), within 48 hours pre-procedure, to exclude atrial thrombus or other structural contraindications for an ablation procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01570361
Study Brief:
Protocol Section:
NCT01570361