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NCT Number: NCT06973031

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation (PAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westpfalz-Klinikum GmbH Kaiserslautern

Kaiserslautern, 67655, Germany

Location status: Recruiting

Location contact

Westpfalz-Klinikum GmbH Kaiserslautern Hellmut-Hartert-Straße 1, Kaiserslautern, 67655, Germany

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key inclusion criteria:

  • A diagnosis of recurrent symptomatic paroxysmal or persistent AF
  • Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

  • Long-standing persistent AF (sustained >12 months)
  • Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
  • History of thromboembolic events within the past six months
  • Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
  • Any cardiac surgery within the previous six months
  • Prior left atrial ablation or surgical procedure
  • Presence of an implanted cardiac device
  • Body mass index (BMI) >40 kg/m^2
  • Left ventricular ejection fraction (LVEF) <35%
  • Anterior-posterior left atrial (LA) diameter >55mm

Treatment and study plan

Globe Pulsed Field System

Device

Ablation and atrial mapping with the Globe Pulsed Field System

Primary outcomes

  1. Effectiveness endpoint

    Time frame: 12 months

    Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.

  2. Safety endpoint

    Time frame: 7 days

    Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Affairs

CONTACT

[email protected]

+1 (604) 248 8891

Sponsors and collaborators

Lead sponsor

Kardium Inc.

Industry

Registry information

Acronym: GLOBAL-PF

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
Jun 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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