Clinical trial NCT06335082: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
Official title: A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
persistent atrial fibrillation
long-standing persistent atrial fibrillation
pulse field ablation
Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-03-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.

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.

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

Primary outcomes:
measure: Long term effectiveness
timeFrame: 12 months
measure: Long-term safety
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Arrhythmia Institute at Grandview
state: Alabama
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Ventura
country: United States
facility: Community Memorial Health Systems
state: California
city: Delray Beach
country: United States
facility: The Arrythmia Center of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Miami
country: United States
facility: HCA Florida Mercy Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health (Northshore)
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St Vincent -Indianapolis Ascension Healt
state: Indiana
city: West Des Moines
country: United States
facility: MercyOne Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: Norton Heart & Vascular Institute
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of Delaware Valley
state: New Jersey
city: Asheville
country: United States
facility: HCA Research Institute Mission Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: North Charleston
country: United States
facility: HCA - Trident Medical Center
state: South Carolina
city: Austin
country: United States
facility: Ascension Texas Cardiovascular
state: Texas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation (St. Davids)
state: Texas
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Richmond
country: United States
facility: HCA Research Institute - Chippenham Hospital
state: Virginia
Study officials:
References: