Effect of Balloon Cryoablation on Left Atrial Function "CRYO-LA"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Documented paroxysmal atrial fibrillation
- ≥ 18 and ≤ 85 years of age
- Failure of one or more AF Drugs (AFDs).
- Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
- Ability to understand the requirements of the study
- Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria

- Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
- More than 4 cardioversions in the prior year.
- Patients with recent myocardial infarction (less than 2 months) or unstable angina.
- Patients with congestive heart failure (NYHA class III or IV).
- Patients who have experienced any cerebral ischemic event, including any TIA in the preceding 1 month.
- Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure.
- Patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
- Patients whose life expectancy is less than one year.