A RWS of the FARAPULSE in A Chinese Population With PAF

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05493852
• Other study ID #: PF109
• Status: Active, not recruiting
• Start date: February 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• FARAPULSE Pulsed Field Ablation System
Patients diagnosed as paroxysmal atrial fibrillation with indication of ablation will be treated by FARAPULSE Pulsed Field Ablation System.

Locations

Country	Name	City	State
China	Boao Super Hospital	Bo'ao	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	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.	Day 0
Primary	Primary Safety Endpoint	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.	7 Days
Secondary	Secondary Effectiveness Endpoints-1	Chronic Success: Proportion of subjects that free from effectiveness events defined as failure without AADs at 12 months post-procedure.	12 Months
Secondary	Secondary Effectiveness Endpoints-2	Proportion of PVs that achieve electrical isolation by using the FARAPULSE Pulsed Field Ablation system only.	12 Months
Secondary	Secondary Effectiveness Endpoints-3	Proportion of chronic success allowing antiarrhythmic drugs (AADs).	12 Months
Secondary	Secondary Safety Endpoints	Proportion of subjects that free from primary safety events defined as above through 7 days after the procedure and free from the following serious procedure-related and/or device-related adverse events at any time through the completion of 12-month follow-up visit.	12 Months