ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKardium Inc.
About this trial
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
Eligibility criteria
Qualifiers
Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
Diagnosis must be confirmed within 12 months before enrollment.
(Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
Subjects between 18 and 75 years of age, inclusive
Disqualifiers
Patients who have contraindications to open heart surgery
Patients from an Intensive Care Unit
Patients with active systemic infection (sepsis)
Patients who have had previous ablation in the left or right atrium
Trial design
Treatments tested in this trial
- Globe Mapping and Pulsed Field Ablation System (Globe PF System)
Treatment groups
175 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov