Actively Recruiting
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe4 Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Led by Kardium Inc. · Updated on 2025-06-16
115
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 device's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ablation and atrial mapping using the Globe Pulsed Field System to treat atrial fibrillation.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety and effectiveness after the procedure.
Visits over 12 months including safety assessment at 7 days and effectiveness evaluation at 12 months
Trial Site Locations
Total: 1 location
1
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany, 67655
Actively Recruiting
Research Team
C
Clinical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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