A RWS of the FARAPULSE in A Chinese Population With PAF
About the study
The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment;
- Subjects whose preoperative diagnosis is PAF confirmed by the clinician;
- De novo ablation procedure for PAF with Class I or IIa recommendations* according to 2018 Chinese expert consensus on atrial fibrillation therapy;
- Subjects who are able and willing to provide the defined observational data and/or participate in baseline and follow-up evaluations for the full study;
- Subjects who are willing and capable of providing informed consent.
EXCLUSION CRITERIA
Exclusion Criteria:
- Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure;
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
- Subjects with any known contraindication to AF ablation with FARAPULSE Pulsed Field Ablation system, anticoagulation therapy, or contrast media in the judgment of the investigator or subjects unwillingness to use systemic anticoagulation
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Paroxysmal Atrial Fibrillation
Age (in years)
18 - 75
Participants needed
30
Est. Completion Date
Dec 31, 2024
Treatment type
Observational
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov identifier
NCT05493852
Study number
PF109
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?