Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
- Paroxysmal Atrial Fibrillation
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip. - Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD. - Age 18 years or older.
- Previous surgical or catheter ablation for atrial fibrillation. - AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. - Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days. - Valve repair or replacement or presence of a prosthetic valve. - CABG surgery within the past 6 months (180 days). - Any carotid stenting or endarterectomy within the past 6 months. - Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months. - Documented left atrium (LA) thrombus within 1 day prior to the index procedure. - Documented LA size > 50 mm. - Documented LVEF < 40%. - Contraindication to anticoagulation (e.g., heparin). - MI/PCI within the past 2 months. - Documented thromboembolic event (including transient ischemic attack) within the past 12 months. - 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. - Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD). - Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
|Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator||
Second Arm (variable flow)
|subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator||
- Biosense Webster, Inc.
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal. the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.