Status:
NOT_YET_RECRUITING
A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation (Paroxysmal)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the F...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years.
- Documented diagnosis of paroxysmal atrial fibrillation (PAF), defined as typical AF electrographic characteristics (absence of P waves with irregular fibrillatory waves) recorded on 12-lead ECG or symptomatic Holter monitoring, with each episode lasting less than 7 days.
- Symptomatic despite attempted antiarrhythmic drug therapy.
- Scheduled to undergo initial catheter ablation procedure.
- Voluntarily provided written informed consent.
Exclusion
- AF secondary to electrolyte imbalance, thyroid disorders, or other reversible/non-cardiac causes.
- Persistent atrial fibrillation.
- Presence of persistent left superior vena cava.
- Contraindications to pulsed field ablation (e.g., left atrial appendage thrombus, post-atrial septal defect device closure, permanent metallic implants in the left atrium) or contraindications to anticoagulant therapy.
- Unsuitable for deep sedation/anesthesia per operator assessment.
- Life expectancy less than 1 year.
- Other conditions deemed inappropriate for inclusion by the investigator.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07162597
Start Date
October 1 2025
End Date
June 30 2028
Last Update
September 9 2025
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