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A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03714178
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Farapulse, Inc.

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE October 20, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
The primary safety endpoint for this study is the Composite Safety Endpoint (CSE) defined as the incidence of early-onset and late-onset serious adverse events (SAEs) which are device- or procedure-related. [ Time Frame: 30 Days ]
Early onset (within 30 days of any endocardial ablation for atrial fibrillation). Occurrence of any one of the below events will qualify a subject as a safety failure.
  • Death
  • Myocardial infarction (MI)
  • Persistent diaphragmatic paralysis
  • Stroke or transient ischemic attack (TIA)
  • Peripheral or organ thromboembolism
  • Pericarditis
  • Cardiac tamponade / perforation
  • Vascular access complications
  • Hospitalization (initial or prolonged)*
  • Heart block Late onset (any time during follow-up)
  • Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)
  • Atrio-esophageal fistula * Excludes hospitalization (initial & prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
Feasibility: Pulmonary Vein Isolation [ Time Frame: 1 Day (Acute) ]
The proportion of subjects that achieve Acute Procedural Success (APS) defined as the percutaneous endocardial creation of a complete, electrically isolating set of lesions around the ostia of the pulmonary veins (PVI) using the FARAPULSE Endocardial Ablation System during the first procedure, as clinically assessed by entrance and/or exit block performed ≥ 20 minutes after the last PVI lesion is made.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Official Title  ICMJE PEFCAT: A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Brief Summary PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial fibrillation.
Detailed Description Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the FARAPULSE Endocardial Ablation System. Subjects will be followed at 7 days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field) catheter ablation procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: FARAPULSE Endocardial Ablation System
Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Study Arms  ICMJE Experimental: FARAPULSE Endocardial Ablation
Subjects who are treated with the FARAPULSE Endocardial Ablation System for paroxysmal atrial fibrillation.
Intervention: Device: FARAPULSE Endocardial Ablation System
Publications * Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2019)
80
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with documented drug resistant symptomatic PAF who have:

    1. Confirmed AF: Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, telemetry strip or similar, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
    2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
    3. Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug (AFD; class I - IV) for efficacy and / or intolerance
  2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
  3. Patient participation requirements:

    1. Lives locally
    2. Is willing and capable of providing Informed Consent to undergo study procedures
    3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria:

  1. Use of amiodarone within 3 months prior to enrollment
  2. Atrial fibrillation that is any of the following

    1. Persistent (by diagnosis or duration > 7 days)
    2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
    3. Requires ≥ 3 cardioversions in the preceding 12 months
  3. Cardiac anatomical exclusions by imaging within 3 months prior to enrollment:

    1. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
    2. Left ventricular ejection fraction ≤ 40% as documented by TTE
  4. Any of the following cardiac procedures, implants or conditions:

    1. Clinically significant arrhythmias other than AF
    2. Hemodynamically significant valvular disease
    3. Prosthetic heart valve
    4. NYHA Class III or IV CHF
    5. Previous endocardial or epicardial ablation or surgery for AF
    6. Atrial or ventricular septal defect closure
    7. Atrial myxoma
    8. Left atrial appendage device or occlusion
    9. Pacemaker, ICD or CRT
    10. Significant or symptomatic hypotension
    11. Bradycardia or chronotropic incompetence
    12. History of pericarditis
    13. History of rheumatic fever
  5. Any of the following within 3 months of enrollment:

    1. Myocardial infarction
    2. Unstable angina
    3. Percutaneous coronary intervention
    4. Heart surgery including coronary artery bypass grafting
    5. Heart failure hospitalization
    6. Stroke or TIA
    7. Clinically significant bleeding
    8. Pericarditis or pericardial effusion
    9. Left atrial thrombus
  6. History of blood clotting or bleeding abnormalities.
  7. Contraindication to, or unwillingness to use, systemic anticoagulation
  8. Contraindications to CT or MRI
  9. Sensitivity to contrast media not controlled by premedication
  10. Women of childbearing potential who are pregnant, lactating or not using birth control
  11. Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to

    1. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
    2. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
    3. Chronic renal insufficiency of < 60 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant
    4. Active malignancy or history of treated cancer within 24 months of enrollment
    5. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
    6. Clinically significant infection
    7. Predicted life expectancy less than one year
  12. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
  13. Current or anticipated enrollment in any other clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Schneider 6176867661 kschneider@farapulse.com
Listed Location Countries  ICMJE Czechia,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714178
Other Study ID Numbers  ICMJE CS0267
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Farapulse, Inc.
Study Sponsor  ICMJE Farapulse, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petr Neuzil, MD, PhD Nemocnice Na Homolce
PRS Account Farapulse, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP