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ADVENT Post Approval Study | Clinical Trials | Clareo Health

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ADVENT Post Approval Study

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

NCT06431815•Boston Scientific Corporation

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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.

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 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.

Locations (30)

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

Key Dates

Start Date

September 25, 2024

Primary Completion Date

October 1, 2028

Completion Date

October 1, 2029

Last Updated

March 2, 2026

Enrollment

228

ACTUAL participants

Conditions

Paroxysmal Atrial Fibrillation

Interventions

FARAPULSE™ Pulsed Field Ablation System

DEVICE

Burst Stimulation for Paroxysmal Atrial Fibrillation

NCT07281898

Paroxysmal Atrial Fibrillation

View study

RECRUITINGPHASE4

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

NCT06765356

Persistent Atrial FibrillationParoxysmal Atrial Fibrillation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ADVENT Post Approval Study

Inclusion Criteria

Exclusion Criteria

Burst Stimulation for Paroxysmal Atrial Fibrillation

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

VOLT CE Mark Study

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation