TactiCath® Prospective Effectiveness Pilot Study (EFFICAS II)

This is an interventional basic science trial for Paroxysmal Atrial Fibrillation Read More

Inclusion Criteria:

• Patient is at least 18 years of age but not over 75 years of age
• Patient has at least one episode of sustained (>30s) paroxysmal atrial fibrillation documented by 12-lead ECG, holter monitor, transtelephonic event monitor, telemetry strip, or Pacemaker respectively implantable cardioverter defibrillator (ICD) within 12 months prior to enrolment
• Patient has symptomatic paroxysmal atrial fibrillation (PAF) refractory or intolerant to at least one Class I-IV anti-arrhythmic drug
• Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up scheme
• Patient provides written informed consent prior to enrolment in the study

Exclusion Criteria:

• Not adhering to inclusion criteria
• Active systemic infection
• Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery
• Reversible causes of Arrhythmia including thyroid disorders, acute alcohol intoxication, recent (less than 3 months) major surgical procedures
• Patient has a left atrial diameter > 5.0 cm
• Patient has persistent or long-standing persistent atrial fibrillation (AF)
• Left ventricular ejection fraction < 35%
• New York Heart Association (NYHA) class III or IV
• Previous left atrial heart ablation procedure, either surgical or catheter ablation
• Patient has an intracardiac mural thrombus or has had a ventriculotomy or atriotomy
• Patient has moderate or severe structural heart disease as demonstrated by transthoracic or trans-esophageal echocardiogram of all four chambers of the heart (ventricular dysfunction or valve disease)
• Tricuspid or mitral valve replacement or repair
• If female of childbearing potential - pregnant or breastfeeding
• Patient has a bleeding diathesis or suspected pro-coagulant state
• Patient has contraindication to long-term antithromboembolic therapy (e. g. acetylsalicylic acid, heparin, warfarin)
• Presence of condition that precludes appropriate vascular access
• Heart disease in which corrective surgery is anticipated within 6 months
• Renal failure requiring dialysis
• Patient has a known sensitivity to contrast media (if needed during the procedure) that cannot adequately be controlled with pre-medication (or totally excluded)
• Patient has other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
• Patient is currently participating in another clinical trial
• Patient is unlikely to survive over one year