N/A
N=30
A RWS of the FARAPULSE in A Chinese Population With PAF
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT05493852 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Acute Procedural Success — 30 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- FARAPULSE Pulsed Field Ablation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute Procedural Success |
30 | — |
| PRIMARY Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure |
— | — |
Summary
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.
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT05493852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.