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
Recruiting
N/A
Interventional Study
Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 115 (estimated)
- Sponsor
- Kardium Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 reversibl…
Contacts