Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

Study Overview
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Brief Summary
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The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.

Detailed Description
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This Registry is intended to obtain purely observational and prospective real world data about the cardiac ablation procedure in subjects treated with the FARAPULSE™ Pulsed Field Ablation system, to provide continued evidence on the safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System when used per hospitals' standard of care, and to learn the effect of the Pulsed Field Ablation treatment on Quality Of Life in a real-world setting. The study will enroll approximately 1000 to 1500 subjects, in up to 100 sites in Europe (with the potential for expansion of the study to Middle East, Africa and/or Asia Pacific).

Official Title
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Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: FARAPULSE Pulsed Field Ablation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care Subjects who are willing and capable of providing informed consent Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law Exclusion Criteria: Subjects with a current interatrial baffle or patch Subjects with a known or suspected atrial myxoma Subjects with a myocardial infarction within 14 days prior to enrollment Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA) Subjects who do not tolerate anticoagulation therapy Subjects with an active systemic infection * Subjects with a presence of atrial known thrombus * Subjects with a known inability to obtain vascular access Subjects who are pregnant or planning to be pregnant Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (eg. ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure/unstable angina) and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels) Subjects with a life expectancy of ≤ 1 year per investigator's opinion Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FARAPULSE Pulsed Field Ablation system|Any subject who has signed the informed consent and for whom the FARAPULSE Pulsed Field Ablation system has been inserted into the body, and pulsed field ablation treatment has been received, are assigned to the treatment group.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Failure-free rate at 12 months post index procedure | 12 monhts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Composite of device- or procedure-related serious adverse events at early onset or chronic onset | 12 months |