A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

Launched by HEART RHYTHM CLINICAL AND RESEARCH SOLUTIONS, LLC · Mar 21, 2024

Keywords

ClinConnect 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). All types of AF including paroxysmal, persistent and long standing persistent may be included.

The registry has three cohorts: 1) Acute Arm, 2) Symptomatic Monitoring Only Arm, and 3) Full Monitoring Arm. In the Acute Arm, patient assessments will occur at pre- procedure and procedure visits. In both the Symptomatic Monitoring Only Arm and the Full Mon...

Gender

ALL

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
• • De Novo ablation unless it is a repeat procedure for a subject whose index procedure is also included in the registry
• • 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
• • Prior left atrial ablation (catheter or surgical)
• • Currently receiving inotropic or mechanical support
• • 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