A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

Korábbi kezelés

• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
• Previous left atrium (LA) ablation or surgery
• Documented severe dilatation of the LA (left anterior descending artery [LAD] >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
• Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
• Prior diagnosis of pulmonary vein stenosis
• Current enrollment in an investigational study evaluating another device or drug

Más betegség

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
• Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
• Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
• Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
• Unstable angina within 6 months
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Acute illness, active systemic infection, or sepsis
• Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) left atrial appendage occlusion (LAAO) device or other implanted metal cardiac device within cardiac space that may interfere with the energy field created during the ablation procedure
• Presence of a condition that precludes vascular access

Laborértékek

• Documented severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to enrollment

Életkor

• 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

Egyéb

• Participants known to require ablation outside the pulmonary vein (PV) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia, and Wolff-Parkinson-White), except cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
• Documented LA thrombus by imaging within 48 hours of the procedure
• Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months
• Significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Pre-existing hemi diaphragmatic paralysis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
• Severe mitral regurgitation (Regurgitant volume greater than or equal to [>=] 60 milli liter (mL)/beat, Regurgitant fraction >= 50%, and/or Effective regurgitant orifice area >= 0.40 cm\^2)
• Life expectancy less than 12 months
• Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

• Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at least two symptomatic atrial fibrillation (AF) episodes within last six months from enrollment and (b) at least one AF episode electrocardiographically documented by electrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment
• Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements