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

NCT07236619 | Recruiting

• 1 other identifier: NL-010058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal AF

Keywords

Varipulse; Catheter ablation; Atrial fibrillation; Paroxysmal atrial fibrillation; Pulmonary vein isolation

Outcome Measures

Primary Outcomes (1)

• Percentage of pulmonary veins which shows reconnection during the repeat procedure 2-3 months after the index procedure

  During the repeat procedure (2-3 months after the index procedure) the number of pulmonary veins which shows reconnection will be determined. The primary outcome measure is the percentage of pulmonary veins with reconnection.

  PV reconnection will be determined in the period from 2 to 3 months after the index procedure.

Secondary Outcomes (3)

• Extent of low voltage area in the left atrium identified at the repeat procedure 2-3 months after the index procedure

  Low voltage area will be determined in the period from 2 to 3 months after the index procedure.

• One-year freedom from atrial arrhythmia after a blanking period of 3 months.

  From 3 to 12 months after the index procedure.

• Percentage of patients with a procedure-related complication

  From the index procedure till the 1-year follow-up visit.

Study Arms (1)

VariPulse treatment group

EXPERIMENTAL

Patients with paroxysmal AF undergoing treatment with the VariPulse catheter

Device: Pulmonary vein isolation with the VariPulse catheter

Interventions

Pulmonary vein isolation with the VariPulse catheter DEVICE

Pulmonary vein isolation with the VariPulse catheter

VariPulse treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sing-Chien Yap, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sing-Chien Yap, MD, PhD

CONTACT

+31650031551; s.c.yap@erasmusmc.nl

Bakhtawar K Mahmoodi, MD, PhD, MPH

CONTACT

+31611828388; b.mahmoodi@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist-Electrophysiologist

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: September 27, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)