ADVENT Post-Approval Study

Paroxysmal Atrial Fibrillation Clinical Trial

— ADVENT PAS  

Official title:

Prospective, Multi-site Safety and Effectiveness Post-Approval Study of FARAPULSE Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431815
• Other study ID #: PF304
• Status: Not yet recruiting
• Start date: October 2024
• Est. completion date: October 2029

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: Erin L Feddema, MPH
• Phone: +1 651-582-5077
• Email: erin.feddema[@]bsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Description:

The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: October 2029
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System*;

• Subjects who are willing and capable of providing informed consent;

• Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site;

• Subjects who are of legal age to give informed consent specific to the national law.

• Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.

For the LUX-Dx Sub-Study:

• Subjects with an existing LUX-Dx, inserted = 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.

Exclusion Criteria:

• Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU);

• Subjects with any prior LA ablation;

• Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);

• Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);

• Life expectancy of < 1 year, per investigator's medical judgement.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• FARAPULSE™ Pulsed Field Ablation System
De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	The primary safety endpoint is defined as the primary safety event rate at 12 months post-Index Procedure. Primary safety events will consist of a composite of the following serious procedure-related and device-related adverse events: Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later.; Late Onset: Either of the following with an onset date any time through 12-month post-Index Procedure: Atrial esophageal fistula; Pulmonary vein stenosis (= 70% reduction of diameter)	12 Months
Primary	Primary Effectiveness Endpoint	The primary effectiveness endpoint is treatment success in treated subjects, defined as: Acute Procedural Success AND; Chronic Success, defined as freedom from the following: After the Blanking Period up to the 12-Month Follow-up visit: Occurrence of any Detectable AF, AFL, AT; = 30 seconds in duration from any approved clinical recording devices considered standard of care at the study center (excluding implantable loop recorders) or; = 10-second of continuous AF, AFL or AT documented on any 12-lead ECG; Following interventions: Any cardioversion for AF, AFL or AT; Prescribed a higher dose of any failed Class I or III AAD documented at baseline or any new Class I or III AAD; Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter only)	12 Months