ADVENT Post Approval Study

Running, not enrolling

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT06431815

Run by

Boston Scientific Corporation

People needed

228

Starts

2024-09-25

Expected to finish

2029-10-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Scottsdale Healthcare - Shea — Scottsdale, Arizona, United States
• Alta Bates Summit Medical Center — Oakland, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Florida Heart Rhythm Specialists, PLLC — Fort Lauderdale, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• AdventHealth Tampa — Tampa, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• New York Hospital Queens — Flushing, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Northwell Health — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• East Carolina University Medical Center — Greenville, North Carolina, United States
• Pinnacle Health at Harrisburg Hospital — Harrisburg, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Prisma Health Richland Hospital — Columbia, South Carolina, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Texas Houston Health Science Center — Houston, Texas, United States
• Orion Medical — Houston, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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