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

• Conditions: Atrial Fibrillation

• Registration Number: NCT06335082
• Lead Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

Brief 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).

Detailed Description

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 Monitoring Arm, patient assessments will occur at pre- procedure, procedure, 3 months, and 1 year post ablation. Additionally, the Full Monitoring Arm will assess for asymptomatic recurrence at 6- and 12-months post-ablation.

Sites will be assigned to an arm in which they will enroll under based on their practices current Standard of Care. Sites can only participate in one arm.

The primary purpose of the registry is to assess clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of pulsed field ablation (PFA) in the treatment of patients with AF. Also, to assess the effect of PFA technology implementation on practice patterns, operational workflow and operator experience.

The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship.

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Study Start: 2024-04-24
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-29
• Last Update Posted: 2025-10-31
• Primary Completion: 2026-11-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term effectiveness	12 months	Freedom from atrial arrhythmia recurrence post 90-day blanking period
Long-term safety	12 months	Rate of long-term safety events defined as procedure or device related reportable events (complications) that occur greater than 30 days post ablation. Data for this endpoint will be evaluated from the pooled results of the SMO and FM study arms.

Trial Locations

Locations (25)

Arrhythmia Institute at Grandview; 🇺🇸 Birmingham, Alabama, United States

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Community Memorial Health Systems; 🇺🇸 Ventura, California, United States

The Arrythmia Center of South Florida; 🇺🇸 Delray Beach, Florida, United States

Ascension St. Vincent's; 🇺🇸 Jacksonville, Florida, United States

HCA Florida Mercy Hospital; 🇺🇸 Miami, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Endeavor Health (Northshore); 🇺🇸 Glenview, Illinois, United States

Ascension St Vincent -Indianapolis Ascension Healt; 🇺🇸 Indianapolis, Indiana, United States

MercyOne Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

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