## Protocol Section
### Identification Module
**NCT ID:** NCT06431815

**Acronym:** ADVENT PAS

**Brief Title:** ADVENT Post-Approval Study

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

#### Organization Study ID Info
**ID:** PF304
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Scientific Corporation
### Status Module
#### Completion Date
**Date:** 2029-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boston Scientific Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

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

**Detailed 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).

### Conditions Module

**Conditions:**

- Paroxysmal Atrial Fibrillation

**Keywords:**

- Pulsed Field Ablation

- PFA

- Pulmonary Vein Isolation

- PVI

- Ablation

- Atrial Fibrillation

- AF

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 220

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** FARAPULSE™ Pulsed Field Ablation System

**Other Names:**

- FARAWAVE™ Pulsed Field Ablation Catheter

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Primary Safety Endpoint

**Time Frame:** 12 Months

**Description:** 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)

**Measure:** Primary Effectiveness Endpoint

**Time Frame:** 12 Months

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (PFA) System.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** erin.feddema@bsci.com

**Name:** Erin L Feddema, MPH

**Phone:** +1 651-582-5077

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Paroxysmal Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-31
