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Persistent Atrial FibrillationCS1543NCT05272852

The FARAPULSE PersAFOne III Trial for the Treatment of Persistent Atrial Fibrillation

A study testing FARAPULSE™ Pulsed Field Ablation System Plus in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Persistent Atrial Fibrillation
What is being tested?
FARAPULSE™ Pulsed Field Ablation System Plus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesCzechia
Study dates
3 Feb 2022to 9 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 prior to the Enrollment Date demonstrating 24 hours of continuous AF
  • Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
Show all 11Show fewer
  • 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
  • -

Who cannot join

  • 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)
Show all 50Show fewer
  • 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.
  • -

Trial locations and contacts

2 sites in 1 country.

Czechia2 sites

  • Neuron Medical

    Brno, 637 00

  • Nemocnice Na Homolce

    Prague

Other trials in Czechia

About this study

Official title: PersAFOne III: Feasibility Study of the FARAPULSE Pulsed Field Ablation System Plus - PersAF in the Treatment of Persistent Atrial Fibrillation

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 Pulsed Field Ablation System Plus-PersAF is a feasible and safe treatment for PersAF and associated AFL

Read the detailed description

PersAFOne III study 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.

Being tested
FARAPULSE™ Pulsed Field Ablation System Plus
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FARAPULSE™ Pulsed Field Ablation System PlusDevice

    Ablation using FARAPULSE™ Pulsed Field Ablation System Plus

Study groups in NCT05272852
Study groupRoleWhat they receive
FARAPULSE™ Pulsed Field Ablation System PlusExperimentalAblation using FARAPULSE™ Pulsed Field Ablation System Plus
Receives: Device: FARAPULSE™ Pulsed Field Ablation System Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC

    Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up.

    Early onset (within 30 days of an Index or Remap Procedure)

    • Death
    • Myocardial infarction (MI)
    • Persistent diaphragmatic paralysis
    • Stroke or transient ischemic attack (TIA)
    • Peripheral or organ thromboembolism
    • Pericarditis
    • Cardiac tamponade / perforation
    • Vascular access complications requiring intervention
    • Heart block Late onset (any time during follow-up through 12 months)
    • Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)
    • Atrio-esophageal fistula

    Measured: 30Days-12 months

  2. Primary Effectiveness Endpoint: Acute Procedural Success Acute Vein Success

    Demonstration of Acute Vein Success in all attempted PVs using the FARAPULSE Cardiac Ablation System Plus during the first ablation procedure (Index or Rescheduled Index Procedure)

    Measured: Index Procedure

Secondary outcomes (5)

  1. The Primary Safety Endpoint Assessed at 7 Days

    Percentage of Intent to Treat subjects with one or more of the specified device or procedure related SAEs Endpoint(CSE) defined as the incidence of the following early-onset serious adverse events (SAEs) which are device- or procedure-related, as adjudicated by the Clinical Events and Data Monitoring Committee (CEDMC). Atrioesophageal fistula and PV stenosis components will be assessed for occurrence at any time during follow-up.

    Early onset (within 7 days of an Index or Remap Procedure)

    • Death
    • Myocardial infarction (MI)
    • Persistent diaphragmatic paralysis
    • Stroke or transient ischemic attack (TIA)
    • Peripheral or organ thromboembolism
    • Pericarditis
    • Cardiac tamponade / perforation
    • Vascular access complications requiring intervention
    • Heart block Late onset (any time during follow-up through 12 months)
    • Pulmonary vein (PV) stenosis (> 70% diameter reduction from baseline)
    • Atrio-esophageal fistula

    Measured: 7-Days

  2. The Percentage of Subjects With a Device- or Procedure-related SAE

    Percentage of subjects with one or more device or procedure related SAEs.

    Measured: 12 Months

  3. The Percentage of Subjects With Stroke or TIA

    The percentage of occurrence of stroke or TIA observed in any subjects

    Measured: 12 Months

  4. The Percentage of Subjects Requiring Cardioversions

    The percentage of subjects where cardioversion (s) was performed within the 12-month post index

    Measured: 12 Months

  5. The Percentage of Subjects Requiring an Arrhythmia-related (AF, AFL or AT) Hospitalization

    The percentage of subjects that were hospitalized for arrhythmia-related (AF, AFL or AT) reasons

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start3 Feb 2022
  3. Primary completion9 Feb 2024
  4. Study completion9 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05272852
Sponsor's protocol ID
CS1543
Acronym
CS1543
Status last verified
Jan 2025
First submitted
13 Dec 2021
Last updated
8 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing FARAPULSE™ Pulsed Field Ablation System Plus in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 2 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Composite Safety Endpoint (CSE) Defined as the Incidence of the Following Early-onset and Late-onset Serious Adverse Events (SAEs) Which Are Device- or Procedure-related, as Adjudicated by the CEDMC (time frame: 30Days-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05272852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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