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A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

NCT06973031 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-06-16

No results posted yet for this study

Summary

The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.

Conditions

  • Paroxysmal Atrial Fibrillation (PAF)
  • Persistent Atrial Fibrillation

Interventions

DEVICE

Globe Pulsed Field System

Ablation and atrial mapping with the Globe Pulsed Field System

Sponsors & Collaborators

  • Kardium Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Germany

Study Locations

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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 NCT06973031 on ClinicalTrials.gov