A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulsed Field Ablation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse Pulsed Field Ablation Technology for Atrial Fibrillation
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).
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.
Interventions
- Device Pulsed Field Ablation
Ablation using the Boston Scientific Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF)
Primary outcome measures
- Long term effectiveness [Time frame: 12 months]
- Long-term safety [Time frame: 12 months]
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 (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage)
- De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System.
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 35 centers
- Arrhythmia Institute at Grandview — Birmingham
- Arrhythmia Research Group — Jonesboro
- Sutter Health - California Pacific Medical Center — San Francisco
- Community Memorial Health Systems — Ventura
- South Denver Cardiology Associates — Littleton
- The Arrythmia Center of South Florida — Delray Beach
- Ascension St. Vincent's — Jacksonville
- HCA Florida Mercy Hospital — Miami
- … and 27 more centers
Publications
- Al-Ahmad A, Osorio J, Day J, Wasserlauf J, Nair D, Eckart R, Campbell D, Dukes J, Cuoco F, Costello J, Zagrodzky J, Kessler D, Morales G, Rajendra A, Oza S, Barakat A, Magnano A, Amin A, Silverstein J, Thosani A, Bezenek SM, Zei P, Dai C, Natale A, Horton R; DISRUPT AF Investigators. Patient and Procedural Factors Associated With Same-Day Discharge Following Pulsed Field Ablation for Atrial Fibril PMID 41331670
Identifiers
NCT: NCT06335082 · DISRUPT-AF