RecruitingNot Applicable

Feasibility Study of the FARAFLEX Mapping and PFA System

Belgium, Croatia, Czechia250 participantsStarted 2025-02-17

Plain-language summary

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) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years of age, or older if required by local law
✓. Symptomatic, documented, Persistent AF or Paroxysmal AF
✓. Willing and capable of providing informed consent
✓. Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

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:

What they're measuring

Device or procedure-related Composite Serious Adverse Events (CSAEs)

Timeframe: Ablation Procedure (Day 0) - Day 7; Day 0- Day 30; Day 0- Day 360

Acute Procedural Success

Timeframe: At the end of the ablation procedure

Trial details

NCT IDNCT06510556

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-15

Contact for this trial

Sharda Mehta

800-227-3422 sharda.mehta@bsci.com

View on ClinicalTrials.gov More Atrial Fibrillation trials