Using a new device to map and treat atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the Globe Mapping and Pulsed Field Ablation System for patients with atrial fibrillation (AF). Participants will undergo a catheter ablation procedure using this innovative technology, which aims to improve treatment outcomes for AF. The study will collect clinical data to assess how well the device performs in a real-world setting. It targets individuals who have a documented history of AF and are between the ages of 18 and 75.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF.

   1. Diagnosis must be confirmed within 12 months before enrollment.
   2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
2. Subjects between 18 and 75 years of age, inclusive

Key Exclusion Criteria:

1. Patients who have contraindications to open heart surgery
2. Patients from an Intensive Care Unit
3. Patients with active systemic infection (sepsis)
4. Patients who have had previous ablation in the left or right atrium
5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
8. Patients with New York Heart Association Class III or IV heart failure
9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
10. Bleeding disorder history
11. Patients with a known sensitivity to anesthesia or neuromuscular block agent
12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
13. Myocardial infarction within the last three months
14. Atrioventricular (AV) block II° or III°
15. Left ventricular ejection fraction (LVEF) of less than 35%
16. Unstable angina

Where it's running

• Motol and Homolka University Hospital
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: Motol and Homolka University Hospital — V Úvalu 84/1, 150 00 Prague 5, Czech Republic
• Study coordinator: Clinical Affairs
• Email: Clinical.Affairs@kardium.com
• Phone: +1 (604) 248 8891

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.