Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation (PersAFOne)
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ClinicalTrials.gov Identifier: NCT04170621 |
Recruitment Status :
Recruiting
First Posted : November 20, 2019
Last Update Posted : May 3, 2022
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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 |
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, 2022 |
Estimated Study Completion Date : | December 18, 2022 |

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 |
- 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

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

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
Contact: Christopher Schneider | 650-422-3633 | kschneider@farapulse.com |
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 |
Responsible Party: | Farapulse, Inc. |
ClinicalTrials.gov Identifier: | NCT04170621 |
Other Study ID Numbers: |
CS0607 |
First Posted: | November 20, 2019 Key Record Dates |
Last Update Posted: | May 3, 2022 |
Last Verified: | April 2022 |
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 |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |