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Enrolling By Invitation
NCT06335082
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
Conditions: Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 10000
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Location: Arrhythmia Institute at Grandview Birmingham Alabama
Summary
The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF).
Eligibility Criteria
Inclusion Criteria:
* Patients who, in the opinion of the Investigator, are candidates for ablation for AF
* Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
* De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
* 18 years of age or older
* Able and willing to participate in baseline and follow up evaluations for the full length of the registry
Exclusion Criteria:
* Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor
* Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock.
* In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator
Source: ClinicalTrials.gov (NCT06335082). StuddyBuddy aggregates publicly available trial information.