POLARx™ versus Arctic Front Advance™ Cryoablation Systems for Patients with Atrial Fibrillation.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: Cryoablation for atrial fibrillation with the POLARx™ Cryoablation System. Pulmonary vein isolation (PVI) will occur once during the trial following randomisation. PVI will take approximately 1.5‐2 hours. This will be performed by a cardiac electrophysiologist. CONDITION: Atrial Fibrillation; ; Atrial Fibrillation Cardiovascular ‐ Other cardiovascular diseases PRIMARY OUTCOME: Total Ablation Time ‐ recorded at the time of ablation from patient notes [At time of cryoablation ] Total Procedure Time ‐ recorded at the time of ablation from patient notes ; [At time of cryoablation ] SECONDARY OUTCOME: Any symptomatic AF recurrence assessed on follow‐up visits at 3, 6, 9 and 12 months. ; 1. Patient medical records ; 2. Patient questioning by the clinician at follow‐up[3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] Burden of recurrent documented AF episodes assessed on follow‐up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors. ; [3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] Burden of recurrent symptomatic documented AF episodes assessed on follow‐up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors. ; ; [3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] Complications of pulmonary vein isolation assessed just after ablation and at 3, 6, 9 and 12 months following the procedure. These complications include: ; o Groin site complication ; o Transient phrenic nerve palsy ; o Persistent phrenic nerve palsy ; o Cardiac Tamponade ; o Atrio‐oesophageal fistula ; o Pulmonary vein stenosis ; o Ischaemic Stroke ; o Death from any cause ; These will be assessed via ; 1. Documentation from the procedure ; 2. Patient questioning at follow‐up ; 3. Review of medical records within the health network[12 months post‐ablation] Hospitalisation as assessed on follow‐up visits at 3, 6, 9 and 12 months. ; This will be assessed via ; 1. Patient medical records ; 2. Patient questioning by the clinician at follow‐up[3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] Major adverse cardiac and cerebrovascular events (MACCE) (non‐fatal MI, non‐fatal stroke, CV death, cardiac hospitalisation due to heart failure). This will be assessed through a combination of patient medical records and clinical follow‐up at 3, 6, 9 and 12 months after ablation. [3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] Time to recurrence of AF assessed on follow‐up visits at 3, 6, 9 and 12 months and based on outpatient holter monitors. ; [3 months post‐ablation ; 6 months post‐ablation ; 9 months post‐ablation ; 12 months post ablation ] INCLUSION CRITERIA: • Age between 17‐80 years. • Have permanent or paroxysmal AF. • Are referred for AF ablation after failure of at least one antiarrhythmic drug (AAD).
Epistemonikos ID: 4ea902c702f7e1dee17085d1201c04a15dd26c92
First added on: Aug 24, 2024