ADVENT Post Approval Study

NCT06431815 | Active Not Recruiting FDA Device

• 1 other identifier: PF304
• Study Type: observational
• Target: 228
• Locations: 4 countries
• Sites: 30

Brief Summary

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

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Pulsed Field Ablation; PFA; Pulmonary Vein Isolation; PVI; Ablation; Atrial Fibrillation; AF

Outcome Measures

Primary Outcomes (2)

• Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.

  * Early Onset: Acute primary safety endpoint events, events occurring up to 7 days post-Index Procedure or hospital discharge, whichever is later including serious procedure-related and device-related adverse events. * Death * Myocardial infarction (MI) * Persistent phrenic nerve palsy * Stroke/Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Peripheral or organ thromboembolism * Cardiac tamponade / perforation * Pericarditis * Pulmonary edema * Serious vascular access complications * Heart block * Gastric motility / pyloric spasm disorders * Severe hemolysis with subsequent renal injury or significant anemia * 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

• Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.

  \- Acute Procedural Success: Acute procedural success is defined as isolation of all clinically relevant pulmonary veins or anatomical equivalents using the FARAPULSE Pulsed Field Ablation System only 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 Antiarrhythmic Drug (AAD) documented at baseline or any new Class I or III AAD * Re-ablation for AF, AFL or AT (other than for cavotricuspid isthmus (CTI)-dependent flutter only)

  12 Months

Interventions

FARAPULSE™ Pulsed Field Ablation System DEVICE

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

Also known as: FARAWAVE™ Pulsed Field Ablation Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.)
• 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.
• For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (30)

Mobile Infirmary Medical Center

Mobile, Alabama, 36608, United States

Location

Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258, United States

Location

Alta Bates Summit Medical Center

Oakland, California, 94609, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Heart Rhythm Specialists, PLLC

Fort Lauderdale, Florida, 33308, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4504, United States

Location

New York Hospital Queens

Flushing, New York, 11355, United States

Location

Columbia University Medical Center

New York, New York, 10019, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

East Carolina University Medical Center

Greenville, North Carolina, 27834, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0737, United States

Location

University of Texas Houston Health Science Center

Houston, Texas, 77030, United States

Location

Orion Medical

Houston, Texas, 77034, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Sos Cardio Servicoshospitalares Ltda

Florianópolis, Santa Catarina, 88030-000, Brazil

Location

Instituto do Coração do HCFMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

Institut de Cardiologie de Montreal-Hospital

Montreal, Quebec, H1T 1C8, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Quebec, G1V 4G5, Canada

Location

Hospital Regional de Concepcion

Concepción, Biobio, 4070022, Chile

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stavros E Mountantonakis, MD, MBA

  Northwell Health, Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

BR (2); US (25); CL (1); CA (2)