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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06335082
Other study ID # DISRUPT-AF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date January 30, 2027

Study information

Verified date April 2024
Source Heart Rhythm Clinical and Research Solutions, LLC
Contact Deana L Pierce, BS
Phone 17606379109
Email DPierce@hrcrs.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 900
Est. completion date January 30, 2027
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Texas Cardiac Arrhythmia Research Foundation (St. Davids) Austin Texas
United States Arrhythmia Institute at Grandview Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Endeavor Health (Northshore) Glenview Illinois
United States Cardiovascular Associates of Delaware Valley Haddon Heights New Jersey
United States Community Memorial Health Systems Ventura California

Sponsors (2)

Lead Sponsor Collaborator
Heart Rhythm Clinical and Research Solutions, LLC Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Long term effectiveness Freedom from atrial arrhythmia recurrence post 90-day blanking period 12 months
Primary 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. 12 months
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