Paroxysmal atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Nihon University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who underwent a de novo radiofrequency ablation for PAF with a Biosense Webster therapeutic catheter at one of the study sites, as follows: a. from January 2019 to July 2021 with a non-VIZIGO sheath, or b. from July 2020 to July 2021 with a VIZIGO sheath 2. Subjects have follow up data through 12 months post-index procedure, with the exemption of subjects who have died prior to their 12 month follow up visit 3. Subjects aged 18 years or older on the day of the ablation procedure 4. Willing and capable of providing consent according to the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects
Exclusion criteria
Exclusion criteria: 1. Subjects with history of persistent atrial fibrillation or long standing-persistent AF at the time of the ablation procedure 2. Subjects with any prior left atrial ablation or cardiac-cause surgery before the ablation procedure 3. Subjects who were enrolled in a potentially confounding drug or device trial at the time of their ablation procedure or within the 12-month follow-up period post-procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluoroscopy time and radiation dose | — |
Countries
Japan
Contacts
Public ContactEri Suzuki
Johnson & Johnson K.K CMO office Clinical Research
Outcome results
None listed