Lattice vs Pentaspline Comparative Evaluation in Persistent AF

Korábbi kezelés

• Previous catheter or surgical ablation, except right-sided atrial ablation for supraventricular tachycardia or cavotricuspid isthmus ablation for atrial flutter
• Prior pulmonary vein intervention, pulmonary vein stenting, or known severe pulmonary vein stenosis
• Presence of an interatrial baffle, ASD/PFO closure device, or surgical patch that, in the investigator's judgment, precludes safe transseptal access Cardiovascular exclusions
• Inability, unwillingness, or anatomical contraindication (e.g., implant-site skin or soft-tissue pathology, prior radiation, or chest-wall deformity) to undergo ILR implantation

Más betegség

• New York Heart Association (NYHA) functional class III or IV
• Recent acute coronary syndrome, coronary revascularization, cardiac surgery, stroke, or transient ischemic attack within the preceding 90 days
• Severe valvular heart disease or prosthetic heart valve/annuloplasty ring
• History of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF).
• Atrial fibrillation secondary to reversible non-cardiac causes. Other exclusions
• Presence of an insertable cardiac device (pacemaker, ICD, CRT, or pre-existing non-study ILR)

Laborértékek

• Severe renal impairment: eGFR<30 mL/min/1.73 m2 or current/prior renal replacement therapy

Egyéb

• Anatomical and procedural exclusions
• Severe left atrial enlargement: left atrial anteroposterior diameter ≥55 mm or LAVI >50 mL/m2
• Left atrial or left atrial appendage (LA/LAA) thrombus
• Contraindication or intolerance to therapeutic systemic anticoagulation
• Documented baseline hemi-diaphragmatic paresis or paralysis
• Pregnancy or planned pregnancy during the 12-month trial window
• Inability or unwillingness to provide informed consent or complete 12 months of trial follow-up

• Age ≥ 18 years
• Symptomatic AF (EHRA symptom class ≥ II)
• Documented persistent AF (continuous AF for > 7 days and < 365 days), confirmed within 180 days of enrollment by either a 24-hour Holter recording showing continuous AF, or two ECGs from any regulatory-cleared rhythm monitoring device, taken at least 7 days apart, showing continuous AF
• Patients considered eligible for catheter ablation (either refractory/intolerant to ≥1 Class I/III AAD or presenting for first-line ablation per clinical discretion)
• Willing and capable of undergoing insertable loop recorder (ILR) implantation at the index procedure and maintaining the conditions required for automatic remote transmission throughout the 12-month study period
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center