What is the Globe Pulsed Field System studying for atrial fibrillation?

The Globe Pulsed Field System is being studied to evaluate its safety and 12-month effectiveness in treating patients with symptomatic paroxysmal or persistent atrial fibrillation. Kardium Inc. is leading this research to assess a specific ablation strategy combining Pulmonary Vein Isolation and Box Isolation of Fibrotic Areas. Participants can expect careful monitoring during and after treatment to understand how well the device works.

Who may be eligible for this atrial fibrillation clinical trial?

Adults between 18 and 80 years old with symptomatic paroxysmal or persistent atrial fibrillation may be eligible. Participants should have tried at least one antiarrhythmic drug without success or tolerance. People with implanted cardiac devices or recent heart surgeries may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this atrial fibrillation clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study. Participants should plan accordingly for transportation and other costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

All Genders

ID06973031

Study of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas Using the Globe Pulsed Field System to Treat Symptomatic Paroxysmal or Persistent Atrial Fibrillation

Led by Kardium Inc. · Updated on 2025-06-16

115

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new device called the Globe Pulsed Field System in treating patients with symptomatic paroxysmal or persistent atrial fibrillation. This study focuses on a specific ablation method combining Pulmonary Vein Isolation with Box Isolation of Fibrotic Areas BIFA to address irregular heart rhythms. The goal is to assess how well this approach works and how safe it is over a 12-month period. Participants will receive treatment using the Globe Pulsed Field System, which involves ablation and atrial mapping procedures designed to isolate problematic heart tissue. The study tracks the safety of this device within the first 7 days post-treatment and evaluates its effectiveness over one year. Patients included have previously tried or could not tolerate at least one antiarrhythmic drug. During the study, participants will be monitored closely for safety and treatment success at regular intervals, including assessments of heart function and rhythm stability. The primary outcomes measured include treatment effectiveness after 12 months and safety within 7 days of the procedure. The trial will last up to three years, starting in June 2025 and ending in June 2028, ensuring comprehensive follow-up and evaluation of the devices impact.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 80 years
Diagnosis of recurrent symptomatic paroxysmal or persistent atrial fibrillation
Failure or intolerance of at least one antiarrhythmic drug Class I or III

You will not qualify if you...

Long-standing persistent atrial fibrillation sustained for more than 12 months
Atrial fibrillation due to a reversible or non-cardiac cause
History of thromboembolic events within the past six months
Myocardial infarction or percutaneous coronary intervention within the last three months
Cardiac surgery within the previous six months
Prior left atrial ablation or surgical procedure
Presence of an implanted cardiac device
Body mass index over 40 kg/m2
Left ventricular ejection fraction less than 35%
Anterior-posterior left atrial diameter greater than 55 mm

Research Team

Clinical Affairs

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