FARAFLEX Mapping and PFA System for Atrial Fibrillation

Feasibility Study of the FARAFLEX Mapping and PFA System

Recruiting N/A Interventional Study
Atrial Fibrillation Persistent Atrial Fibrillation Paroxysmal AF
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Boston Scientific Corporation · Industry
Who this trial is looking for

This trial is looking for adults with persistent or paroxysmal atrial fibrillation who are experiencing symptoms. Participants will evaluate the safety and effectiveness of a new catheter treatment.

Are You a Good Fit for This Trial?
Rules you out Known severe coronary diseaseActive malignancyHeart failure

You may be able to join if

  • I am 18 years old or older.
  • I have symptoms of persistent or paroxysmal atrial fibrillation.
  • I can provide informed consent.
  • I can attend all follow-up assessments.

You may not be able to join if

  • I have a left atrial size that is too large.
  • I have had previous heart surgery or procedures for atrial problems.
  • I have an untreated atrial thrombus.
  • I have a history of serious heart conditions like heart failure.
  • I have had a heart attack or cardiac surgery in the last 90 days.
  • I have severe lung or kidney problems.
  • I am currently pregnant or plan to become pregnant soon.
  • I have an active cancer diagnosis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years of age, or older if required by local law 2. Symptomatic, documented, Persistent AF or Paroxysmal AF 3. Willing and capable of providing informed consent 4. Willing and capable of participating in all follow-up assessments and testing associated with this clini…
Contacts

Sharda Mehta

800-227-3422

sharda.mehta@bsci.com

CONTACT

Maria Grazia Pietropaolo

+393463514999

MariaGrazia.Pietropaolo@bsci.com

CONTACT