NCT05493852Completed
A RWS of the FARAPULSE in A Chinese Population With PAF
A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 31 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 2 Aug 2022
- Start date
- 24 Feb 2023
- Primary completion date
- 21 Aug 2023
- Lead sponsor
- Boston Scientific Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT05493852
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 24 Feb 2023 to the primary completion date, 21 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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 who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boao Super Hospital Coordinator of this site? Confirm its status | Bo'ao | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.