Persistent AF who are scheduled to undergo an ablation procedure using the QDOT MICRO catheter.
Conditions
Interventions
None listed
Sponsors
Goya Masahiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must meet ALL of the following inclusion criteria to be eligible for enrollment into the study: 1.Signed and dated the informed consent form.* 2.Diagnosed with drug refractory symptomatic persistent atrial fibrillation lasting longer than 7 days but less than or equal to 12 months 3.Indicated for AF ablation for symptomatic persistent atrial fibrillation according to the latest version of JCS/JHRS guidelines (at investigators discretion). 4.Scheduled to undergo AF ablation for treatment of their persistent AF using QDOT MICRO catheter 5.Age 18 years or older 6.Able and willing to comply with all pre-, post- and follow-up testing and requirement as per hospital standard of care *When a legal representative of the subject signs the consent, his/her legally acceptable representative must have signed and dated the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects must not meet ANY of the following exclusion criteria to be eligible for enrollment into the study: 1.Previous surgical or catheter ablation for atrial fibrillation. 2.Presenting any contra-indication for the use of QDOT MICRO catheter, as indicated in the IFU 3.Women of childbearing potential who are, or plan to become, pregnant during the study 4.Not expected to participate in the study for 12-month follow up post-procedure. 5.Currently enrolled or planning to participate in any interventional study 6.Uncontrolled heart failure or New York Heart Association (NYHA) function class IV 7.Life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Safety -Incidence of Primary Adverse Events (PAEs) related to the device and/or procedure occurring within 7 days post index procedure. Long-term Effectiveness -Freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) episodes based on electrocardiographic data (episodes >=30 seconds) during the effectiveness evaluation period (91-365 days post index procedure). | — |
Contacts
Public ContactEri Suzuki
Johnson & Johnson K.K. Medical Campany
Outcome results
None listed