A RWS of the FARAPULSE in A Chinese Population With PAF
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT05493852
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> 1. Subjects who are = 18 and = 75 years of age on the day of enrollment;<br><br> 2. Subjects whose preoperative diagnosis is PAF confirmed by the clinician;<br><br> 3. De novo ablation procedure for PAF with Class I or IIa recommendations* according to<br> 2018 Chinese expert consensus on atrial fibrillation therapy;<br><br> 4. Subjects who are able and willing to provide the defined observational data and/or<br> participate in baseline and follow-up evaluations for the full study;<br><br> 5. Subjects who are willing and capable of providing informed consent.<br><br>Exclusion Criteria:<br><br> 1. Subjects who, in the judgment of the investigator, have a life expectancy of less<br> than one year before the procedure;<br><br> 2. Women of childbearing potential who are, or plan to become, pregnant during the time<br> of the study;<br><br> 3. Subjects with any known contraindication to AF ablation with FARAPULSE Pulsed Field<br> Ablation system, anticoagulation therapy, or contrast media in the judgment of the<br> investigator or subjects unwillingness to use systemic anticoagulation<br><br> 4. Subjects who are currently enrolled in another investigational study or registry<br> that would directly interfere with the current study.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint;Primary Safety Endpoint
- Secondary Outcome Measures
Name Time Method Secondary Effectiveness Endpoints-1;Secondary Effectiveness Endpoints-2;Secondary Effectiveness Endpoints-3;Secondary Safety Endpoints