Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation

Korábbi kezelés

• History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT).
• Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
• Previous left atrial (LA) ablation or LA surgery.
• Previous pulmonary vein stenosis or pulmonary vein stent.
• Contraindication to systemic oral anticoagulation therapy
• Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation).
• Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial.
• Currently participating or anticipated to participate in interventional clinical trials of drug, device or biologic agents that could affect the results of this trial.

Más betegség

• Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery).
• NYHA Class 4 heart failure.
• Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
• Chronic Kidney Disease ≥ Stage 4.
• Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded).
• History of thromboembolic events in the 6 months preceding enrollment.
• Primary pulmonary hypertension
• Rheumatic heart disease
• Active systemic infection

Laborértékek

• Left ventricular ejection fraction \<35%.

Egyéb

• Persistent and permanent AF.
• Pre-existing hemi-diaphragmatic paralysis.
• Active intracardiac thrombus.
• Hypertrophic cardiomyopathy
• Patients with mechanical mitral prosthetic valves
• Known adverse reaction to adenosine.
• Pregnant subjects.
• Thrombocytosis, thrombocytopenia and other hypercoagulable states
• Patients with life expectancy less than 12 months.
• Unwilling or unable to comply fully with study procedures and follow-up.

• Age ≥18 years on the date of consent for the trial.
• Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).
  • At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder.
• Subjects must be able to provide informed consent.