NCT07236619

Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation

Durability of Pulmonary Vein Isolation Using a Variable-Loop Biphasic Pulsed Field Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation: a Prospective Remapping Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The VARIFY study is designed to find out how durable pulmonary vein isolation (PVI) is after treatment with the VARIPULSE pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation (AF). AF is a common heart rhythm disorder caused by abnormal electrical signals coming from the pulmonary veins. In a PVI procedure, these veins are electrically isolated to prevent AF from recurring. Sometimes, the veins reconnect over time, which can lead to a return of arrhythmia. PFA is a new, non-thermal technology that uses short electrical pulses to safely and precisely treat heart tissue, reducing the risk of damage to nearby structures. The VARIPULSE system is one of these new PFA platforms. In this study, 20 adult patients with paroxysmal AF will undergo PVI using the VARIPULSE system. After 2-3 months, each patient will have a second planned procedure to check whether the pulmonary veins remain isolated. Any reconnections found will be treated immediately. The main goal is to determine how often the pulmonary veins stay durably isolated after the initial VARIPULSE treatment. Secondary goals include assessing the amount of scar tissue in the left atrium, recording any complications, and evaluating rhythm outcomes after one year. The results will help determine how effective and reliable the VARIPULSE system is for long-term treatment of AF.

Detailed description

Rationale: Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation. Pulmonary vein reconnection is associated with recurrence of arrhythmia, thus, durable PVI during the index procedure is important. Recently, pulsed field ablation (PFA) has emerged as a novel nonthermal energy source with high procedural safety and efficacy for PVI. Irreversible electroporation is achieved by the delivery of rapid, high-voltage pulsed electrical fields. Considering differences in catheter design and PFA protocols, it is important to establish PVI durability of the different PFA platforms. In the VARIFY study we will analyze PVI durability of the VARIPULSE platform in patients with paroxysmal AF using a 2-3 months protocol-mandated remapping study regardless of arrhythmia recurrence. Currently, there are no data on PVI durability of the VARIPULSE platform using mandatory remapping. Objective: To assess PVI durability in patients with paroxysmal AF who undergo a firsttime PVI with the VARIPULSE platform. Study design: Prospective, single-center study. Study population: Twenty consecutive adult patients (≥18 years old) with paroxysmal AF who are scheduled to undergo PVI with the VARIPULSE platform. Intervention: Patients will undergo a second invasive procedure 2-3 months after the index PVI. During the second procedure PVI durability will be assessed using high-definition mapping. Any reconnection will be targeted to achieve complete PVI. Main study parameters/endpoints: The primary outcome is the incidence of PV reconnection at the repeat procedure. The secondary outcome include the area of low voltage in the left atrium at the repeat procedure. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: All patients will undergo a repeat invasive procedure. This second procedure is associated with a similar procedural risk as the first procedure. A potential benefit of a mandated repeat procedure is that early pulmonary vein reconnection is identified and treated. Early treatment of pulmonary vein reconnection is associated with a better arrhythmia outcome.

Conditions

• Paroxysmal AF

Interventions

Type	Name	Description
DEVICE	Pulmonary vein isolation with the VariPulse catheter	Pulmonary vein isolation with the VariPulse catheter

Timeline

• Start date: 2025-09-27
• Primary completion: 2026-05-01
• Completion: 2027-03-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Netherlands