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

N/AEnrolling By InvitationNCT06335082

Heart Rhythm Clinical and Research Solutions, LLC10,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Atrial Fibrillation

Interventions

Pulsed Field AblationDEVICE

Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Outcomes

Primary Outcomes

Long term effectiveness

Freedom from atrial arrhythmia recurrence post 90-day blanking period

Time frame: 12 months

Long-term safety

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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