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Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation (PersAFOne)

Primary Purpose

Persistent Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation
Sponsored by
Farapulse, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Study subjects are required to meet all the following inclusion criteria to participate in this study:

  1. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:

    1. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
    2. ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
    3. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
  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:

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

  1. AF that is:

    1. Paroxysmal (longest AF episode < 7days)
    2. Longstanding (has persisted > 12 months or that does not respond to cardioversion if < 12 months)
    3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
  2. Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
  3. Any of the following cardiac procedures, implants or conditions:

    1. Clinically significant arrhythmias other than AF, AFL or AT
    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, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
    10. Significant or symptomatic hypotension
    11. Bradycardia or chronotropic incompetence
    12. History of pericarditis
    13. History of rheumatic fever
    14. History of congenital heart disease with any residual anatomic or conduction abnormality
  4. Any of the following within 3 months of enrollment:

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

    1. Body mass index (BMI) > 40
    2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
    3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
    4. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
    5. Active malignancy or history of treated cancer within 24 months of enrollment
    6. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
    7. Clinically significant infection
    8. Predicted life expectancy less than one year
  11. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
  12. Current or anticipated enrollment in any other clinical study
  13. Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.

Sites / Locations

  • University Hospital of Split
  • Nemocnice Na Homolce

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FARAPULSE Endocardial Ablation

Arm Description

Ablation using the FARAPULSE Endocardial Multi Ablation System

Outcomes

Primary Outcome Measures

Safety at 30 days
Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula

Secondary Outcome Measures

Full Information

First Posted
October 17, 2019
Last Updated
September 25, 2023
Sponsor
Farapulse, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04170621
Brief Title
Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation
Acronym
PersAFOne
Official Title
PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Farapulse, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Detailed Description
This is a prospective, multi-center safety and feasibility study in subjects with persistent AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as cavotricuspid isthmus interruption and other left atrial ablations at the investigator's discretion. Subjects will then be followed at 30 days, 75 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FARAPULSE Endocardial Ablation
Arm Type
Experimental
Arm Description
Ablation using the FARAPULSE Endocardial Multi Ablation System
Intervention Type
Device
Intervention Name(s)
Ablation
Intervention Description
Ablation using the FARAPULSE Endocardial Multi Ablation System
Primary Outcome Measure Information:
Title
Safety at 30 days
Description
Occurrence of primary safety events at 30 days post procedure: death, MI, stroke/TIA, thromboembolism, pericarditis/tamponade, vascular access complications, hospitalization, heart block, PV stenosis, atriosesphageal fistula
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study subjects are required to meet all the following inclusion criteria to participate in this study: Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria: 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 of the Enrollment Date demonstrating 24 hours of continuous AF Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment. 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 < 7days) Longstanding (has persisted > 12 months or that does not respond to cardioversion if < 12 months) Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes Left atrial anteroposterior diameter ≥ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) Any of the following cardiac procedures, implants or conditions: Clinically significant arrhythmias other than AF, AFL or AT Hemodynamically significant valvular disease Prosthetic heart valve NYHA Class III or IV CHF Previous endocardial or epicardial ablation or surgery for AF Atrial or ventricular septal defect closure Atrial myxoma Left atrial appendage device or occlusion Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices Significant or symptomatic hypotension Bradycardia or chronotropic incompetence History of pericarditis History of rheumatic fever History of congenital heart disease with any residual anatomic or conduction abnormality Any of the following within 3 months of enrollment: Myocardial infarction Unstable angina Percutaneous coronary intervention Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy) Heart failure hospitalization Stroke or TIA Clinically significant bleeding Pericarditis or pericardial effusion Left atrial thrombus History of blood clotting or bleeding abnormalities. Contraindication to, or unwillingness to use, systemic anticoagulation Contraindications to CT or MRI Sensitivity to contrast media not controlled by premedication Women of childbearing potential who are pregnant, lactating or not using birth control Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to Body mass index (BMI) > 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.
Facility Information:
Facility Name
University Hospital of Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Nemocnice Na Homolce
City
Prague
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32854842
Citation
Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1068-1080. doi: 10.1016/j.jacc.2020.07.007.
Results Reference
derived

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Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation

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