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Evaluating the safety and effectiveness of a new ablation system for heart rhythm issues

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

Observational Boston Scientific Corporation · NCT06431815

This study is testing a new heart procedure to see if it can safely help people with recurring atrial fibrillation feel better when medications aren't working.

Quick facts

Study typeObservational
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations34 sites (Mobile, Alabama and 33 other locations)
Trial IDNCT06431815 on ClinicalTrials.gov

What this trial studies

The ADVENT Post Approval Study is a global, multicenter, observational study aimed at assessing the long-term safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. This study includes patients who have recurrent symptoms despite medication and are indicated for this specific treatment. Participants will be monitored over time to gather data on the outcomes associated with this ablation technique.

Who should consider this trial

Good fit: Ideal candidates are individuals with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation who are indicated for treatment with the FARAPULSE Pulsed Field Ablation System.

Not a fit: Patients who are not experiencing recurrent symptoms or those who are not indicated for ablation treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients suffering from paroxysmal atrial fibrillation.

How similar studies have performed: Other studies have shown promise with similar ablation techniques, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Mobile, Alabama and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Paroxysmal Atrial FibrillationPulsed Field AblationPFAPulmonary Vein IsolationPVIAblationAtrial FibrillationAF
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.