A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

NCT07227532 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Conditions

Interventions

DEVICE

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Biosense Webster, Inc. Clinical Trial · Biosense Webster, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227532 on ClinicalTrials.gov