Drug refractory and reoccurrence symptomatic paroxysmal and persistent atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subject is over 18 years old of age Planned procedure using commercially available Arctic Front Cardiac Cryoablation Catheter Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) ot authorization per institution and geographical requirements
Exclusion criteria
Exclusion criteria: Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager. Subject with exclusion criteria required by local law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Twelve-month freedom from atrial fibrillation (AF) recurrence 2.Twelve-month freedom from AF / Atrial Flutter (AFL)/Atrial Tachycardia (AT) recurrence 3.Device or procedure related adverse events for cryoablation through 12 months | — |
Countries
Japan,Asia(except Japan),South America,Europe
Contacts
Medtronic Japan Co., Ltd. Clinical and Medical Affairs OU Clinical Division 4