B-PO03-082 ABLATION OF PERSISTENT ATRIAL FIBRILLATION USING A NOVEL CONTACT FORCE CATHETER: PRIMARY RESULTS OF THE PERSIST-END STUDY

Abstract

Catheter ablation is well established as safe and effective for the treatment of Paroxysmal Atrial Fibrillation (AF). Multiple catheter options have been approved and are available. More limited data and fewer approved catheters are available for Persistent AF (PersAF). The Persist-End study was conducted to demonstrate that RF ablation with a magnetic sensor enabled optical contact force (CF) sensing ablation catheter is safe and effective for the treatment of drug-refractory recurrent symptomatic PersAF. The multi-center, prospective, non-randomized IDE study was conducted at 21 sites in the United States and Australia. Enrollment criteria included documented symptomatic PersAF refractory or intolerant to at least one Class I/III AAD. The ablation procedure included isolation of the pulmonary veins and additional non-pulmonary vein triggers per physician discretion. A blanking period (90 days) and therapy consolidation period (90 days) were employed after the initial ablation procedure, followed by a 9-month evaluation period for a total of 15-months follow-up. Subjects were stringently monitored for adverse events, AAD usage, and arrhythmia recurrence. A total of 223 subjects (mean age 65.4± 10.1 yrs, 69.1% male) underwent ablation with the investigational catheter. Pulmonary vein isolation was performed in 100% of procedures, with additional non-PV targets ablated in 68.2% of cases. The average procedure time was 164.6 ± 77.9 min, with RF and fluoroscopy times of 38.4 ± 25.8min and 10.1 ±10.8 min respectively. Lesions were created using an average 37.0 ± 6.5W of power and 11.7 ± 4.0g of CF. The primary adverse event rate within 7 days of the index procedure was 3.1%. The primary effectiveness success rate, defined as freedom from AF/AFL/AT >30s, new or increased dose of Class I/III AAD, repeat ablation, and cardioversion during the evaluation period, was 60.0% at 15 months. Clinical success, defined as freedom from documented symptomatic recurrence, was 89.5% at 15 months. The results are consistent with published literature for other ablation catheters approved to treat PersAF and demonstrate ablation with this CF catheter is safe and effective for the treatment of recurrent symptomatic PersAF.