Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Recruiting
N/A
Interventional Study
Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 571 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
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About This Trial
The goal of this clinical trial is to learn if the FARAFLEX™ Mapping and pulsed field ablation (PFA) System can safely and effectively treat symptomatic, drug-refractory Paroxysmal atrial fibrillation (PAF) and Persistent atrial fibrillation (PersAF). The main question it aims to answer is:
Is the FARAFLEX Mapping and PFA System a safe and effective treatment for patients?
Participants will unde…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. At least 18 years old (or older if required by local law)
2. Symptomatic, documented, drug-refractory paroxysmal or persistent atrial fibrillation (AF).
3. Willing and capable of providing written informed consent
4. Willing and able to comply with all follow-up assessments a…
Contacts