Clinical trial NCT05493852: A RWS of the FARAPULSE in A Chinese Population With PAF
Official title: A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation.

Brief 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.

Detailed description: The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.

The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure.

Primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment;
2. Subjects whose preoperative diagnosis is PAF confirmed by the clinician;
3. De novo ablation procedure for PAF with Class I or IIa recommendations\* according to 2018 Chinese expert consensus on atrial fibrillation therapy;
4. 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;
5. Subjects who are willing and capable of providing informed consent.

Exclusion Criteria:

1. Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure;
2. Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
3. 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
4. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.

Primary outcomes:
measure: Number of Participants With Acute Procedural Success
timeFrame: Day 0
measure: Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure
timeFrame: 7 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Bo'ao
country: China
facility: Boao Super Hospital
state: Hainan
Study officials:
affiliation: Boao Super Hospital
name: Minglong Chen, Dr
role: PRINCIPAL_INVESTIGATOR
References: