Ensayos clínicos

Inclusion Criteria:

• Diagnosed with Symptomatic PAF (Physician’s note indicating recurrent self-terminating AF):
  • At least two (2) symptomatic AF episodes within last six (6) months from enrollment.
  • At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, ECG, Holter monitor, or telemetry strip.
• Failed at least one (1) Class I or Class III AAD as evidenced by recurrent symptomatic AF, contraindication to the AAD, or intolerable side effects to the AAD.
• Age 18 -75 years.
• Able and willing to comply with all pre-, post- and follow-up testing and visit requirements.
• Signed Patient Informed Consent Form.

Exclusion Criteria:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., documented obstructive sleep apnea and acute alcohol toxicity).
• Previous surgical or catheter ablation for AF.
• Patients known to require ablation outside the PV ostia and CTI region (e.g. atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia, and Wolff-Parkinson-White).
• Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
• Any percutaneous coronary intervention within the past 2 month.
• Valve repair or replacement or presence of a prosthetic valve.
• Any carotid stenting or endarterectomy within the past 6 months.
• Coronary artery bypass grafting, cardiac surgery (e.g., ventriculotomy, atriotomy), or valvular cardiac surgical procedure within the past 6 months.
• Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
• LA antero posterior diameter > 50 mm.
• Left Ventricular Ejection Fraction (LVEF) < 40%.
• Contraindication to anticoagulation (e.g., heparin).
• History of blood clotting or bleeding abnormalities.
• Myocardial infarction within the past 2 months.
• Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
• Rheumatic Heart Disease.
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
• Unstable angina.
• Acute illness or active systemic infection or sepsis.
• Diagnosed atrial myxoma or presence of an interatrial baffle or patch.
• Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
• Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
• Enrolled in an investigational study evaluating another device, biologic, or drug.
• Has known pulmonary vein stenosis.
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
• Presence of an inferior vena cava filter.
• Presence of a condition that precludes vascular access.
• Life expectancy or other disease processes likely to limit survival to less than 12 months.
• Presenting contra-indication for the devices (e.g., TTE, Holter, CT, etc.) used in the study, as indicated in the respective instructions for use.

Additional Exclusion Criteria for NAE Subjects:

• Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion).
• Presence of iron-containing metal fragments in the body.
• Unresolved pre-existing neurological deficit.