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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Farapulse, Inc.
• ClinicalTrials.gov Identifier: NCT04170621
• Other Study ID Numbers: CS0607
• First Posted: November 20, 2019
• Last Update Posted: September 4, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes