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

Atrial Fibrillation Clinical Trial

— DISRUPT-AF  

Official title:

A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335082
• Other study ID #: DISRUPT-AF
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

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