Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE⢠Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.
All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE⢠PFA system will be followed for three years.
Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FARAPULSE⢠Pulsed Field Ablation system | Device | no intervention design in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free rate | Failure-free rate at 12 Month post index procedure. | 12 Months |
| Device-or procedure-related SAEs: | Composite of the following device- or procedure-related SAEs: | 7 days and 12 months |
| Procedure- and device related adverse events | All FARAPULSE⢠PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up. | 12 Months and 2 years and 3 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects enrolled in the FARADISE study will be clinically indicated for an ablation procedure with the FARAPULSE⢠Pulsed Field Ablation system, per indication approved in China, per physician's medical judgement, and according to hospitals' standard of care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Lin | Contact | 15810430945 | Hui.Lin@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Tang, Dr | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China/Beijing | 100037 | China |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |