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N/A N=20 Treatment

Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)

Persistent Atrial Fibrillation

Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jan 2024
Primary outcome: Primary: Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs — 0 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Ablation (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boston Scientific Corporation
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
PRIMARY
Composite Safety Endpoint;Proportion of Intent to Treat Subjects With One or More of the Specified Device or Procedure Related SAEs
PRIMARY
Acute Procedural Success; Acute Vein Succes
20

Summary

The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL

Eligibility Criteria

Key Inclusion Criteria: Patients are required to meet all the following inclusion criteria to participate in this study:

  • Age 18-75 Patients with documented drug-resistant symptomatic persistent AF
  • Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
  • ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
  • Holter within 90 days prior to the Enrollment Date demonstrating 24 hours of continuous AF 3. Patient participation requirements:
  • Lives locally
  • Is willing and capable of providing Informed Consent to undergo study procedures
  • Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria

Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:

  • AF that is:
  • Paroxysmal (longest AF episode 12 months or that does not respond to cardioversion if 40
  • Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
  • Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
  • Renal insufficiency with an estimated creatinine clearance <30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
  • Active malignancy or history of treated cancer within 24 months of enrollment
  • Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
  • Clinically significant infection
  • Predicted life expectancy less than one year
  • Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
  • Current or anticipated enrollment in any other clinical study
  • Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.
  • Use of amiodarone after day of index ablation procedure. Patients will cease use of amiodarone on or before the date of the index ablation procedure.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05152966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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