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

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: NCT04170621
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Farapulse, Inc.

Brief Summary:

PersAFOne:

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


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PersAFOne: Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of Persistent Atrial Fibrillation
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : August 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FARAPULSE Endocardial Ablation
Ablation using the FARAPULSE Endocardial Multi Ablation System
Device: Ablation
Ablation using the FARAPULSE Endocardial Multi Ablation System




Primary Outcome Measures :
  1. Safety at 30 days [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170621


Contacts
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Contact: Christopher Schneider 650-422-3633 kschneider@farapulse.com

Locations
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Croatia
University Hospital of Split Recruiting
Split, Croatia, 21000
Contact: Ivan Sikiric         
Principal Investigator: Ante Anic         
Czechia
Nemocnice Na Homolce Recruiting
Prague, Czechia
Contact: Petr Neuzil         
Principal Investigator: Petr Neuzil         
Sponsors and Collaborators
Farapulse, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Farapulse, Inc.
ClinicalTrials.gov Identifier: NCT04170621    
Other Study ID Numbers: CS0607
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes