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The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX™ mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF).
Full description
The objective of this study is to obtain First-in-Human (FIH) experience with the FARFLEX PFA mapping and ablation PFA catheter in the treatment of persistent Atrial Fibrillation (persAF).
Subjects with symptomatic Persistent Atrial Fibrillation will be included in this study.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Atrial exclusions - Any of the following atrial conditions:
Cardiovascular exclusions - Any of the following CV conditions:
Any of the following conditions at baseline:
Any of the following events within 90 Days of the Consent Date:
Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)
Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period
Any of the following health conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to:
Predicted life expectancy less than one (1) year 11. 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 12. Any of the following congenital conditions:
Primary purpose
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Interventional model
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100 participants in 1 patient group
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Central trial contact
Sharda Mehta
Data sourced from clinicaltrials.gov
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