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

Korábbi kezelés

• 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 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)

Más betegség

• Subjects with an active systemic infection \*
• 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

Egyéb

• Subjects with a current interatrial baffle or patch
• Subjects with a known or suspected atrial myxoma
• 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 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

• 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