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

NCT ID: NCT07236619

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-27
• Study Completion Date: 2027-03-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VariPulse treatment group

Patients with paroxysmal AF undergoing treatment with the VariPulse catheter

Group Type: EXPERIMENTAL

Pulmonary vein isolation with the VariPulse catheter

Intervention Type: DEVICE

Pulmonary vein isolation with the VariPulse catheter

Interventions

Pulmonary vein isolation with the VariPulse catheter

Pulmonary vein isolation with the VariPulse catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1) History of symptomatic paroxysmal AF; 2) Participants who are indicated for a PVI according to the 2020 ESC guidelines for the diagnosis and management of AF; 3) Participants who are willing and capable of undergoing a mandatory repeat procedure 2-3 months after the index procedure; 4) Participants whose age is 18-80 years. 5) Participants who are willing and capable of providing informed consent.

Exclusion Criteria: 1) Any known contraindication to an AF ablation or anticoagulation; 2) History of previous LA ablation or surgical treatment of AF, atrial flutter, or atrial tachycardia; 3) AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause; 4) Significant structural heart disease; 5) History of blood clotting or bleeding disease; 6) Severe kidney disease (glomerular filtration rate <30 ml/min/1.73 m2); 7) Stroke or transient ischemic attack <3 months prior to enrollment; 8) Active systemic infection; 9) Pregnant, lactating, or women of childbearing potential who are, or plan to become, pregnant during the time of the study; 10) Participants who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sing-Chien Yap, MD, PhD

Cardiologist-Electrophysiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sing-Chien Yap, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sing-Chien Yap, MD, PhD

Role: CONTACT

s.c.yap@erasmusmc.nl

+31650031551

Bakhtawar K Mahmoodi, MD, PhD, MPH

Role: CONTACT

b.mahmoodi@erasmusmc.nl

+31611828388

Facility Contacts

Sing-Chien Yap, MD, PhD

Role: primary

s.c.yap@erasmusmc.nl

+31650031551

Other Identifiers

NL-010058

Identifier Type: -

Identifier Source: org_study_id