Overview
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures.
Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Description
Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.
Eligibility
Inclusion Criteria:
- Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
- Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
- Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify)
Exclusion Criteria:
- De Novo paroxysmal AF
- AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
- Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement)
- Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
- Myocardial infarction within the past 90 days
- Severe valvular disease or prosthetic valve(s)
- Contraindication to therapeutic anticoagulation
- Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
- Positive pregnancy test
- Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
- Enrollment in another investigational study evaluating another device, biologic or drug