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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    60
  • sponsor
    Farapulse, Inc.
Updated on 8 August 2022
electrocardiogram
fibrillation
catheter ablation
antiarrhythmic drug
persistent atrial fibrillation

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

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, 60 ± 15 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90 day blanking period and other relevant outcome measures.

Details
Condition Persistent Atrial Fibrillation
Treatment ablation
Clinical Study IdentifierNCT05152966
SponsorFarapulse, Inc.
Last Modified on8 August 2022

Eligibility

Yes No Not Sure

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 < 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 prior toenrollment
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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