Atrial ArrhythmiaPFA-AFNCT05113056
AcQForce Pulsed Field Ablation-CE
A study testing Acutus Medical Pulsed Field Ablation System in people with Atrial Arrhythmia and Atrial Fibrillation, run by Acutus Medical at 1 site in Czechia.
Trial summary
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Arrhythmia, Atrial Fibrillation
- What is being tested?
- Acutus Medical Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Nov 2021to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18 to 80 years at time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of AF
- Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Who cannot join
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- Continuous episodes of AF duration lasting longer than 12-months
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- Structural heart disease or cardiac history as described below:
- Left ventricular ejection fraction (LVEF) < 35%
Show all 20Show fewer
- Left atrial size > 60 mm
- Evidence of heart failure (NYHA Class III or IV)
- Unstable angina or ongoing myocardial ischemia
- Recent myocardial infarction
- Severe uncontrolled systemic hypertension
- Moderate or severe valvular heart disease (stenosis or regurgitation).
- Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis.
- Body Mass Index (BMI) > 42 kg/m2
- History of blood clotting or bleeding disease.
- ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- History of obstructive sleep apnea not currently being treated.
- Pregnant or lactating (current or anticipated during study follow-up).
- Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Read the detailed description
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation
- Being tested
- Acutus Medical Pulsed Field Ablation System
- Keywords
- atrial fibrillation, ablation, pulsed field ablation (PFA)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acutus Medical Pulsed Field Ablation SystemDevice
All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Non-randomized | Experimental | All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation. Receives: Device: Acutus Medical Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who are free from device/procedure related Major Adverse Events
The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.
Measured: 6 months
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device
Measured: 20 minutes post ablation
Secondary outcomes (2)
Analysis of all identified SAEs, SADEs, and UADEs
The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs).
Measured: 12 months
Subjects with freedom from an atrial arrhythmia
The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 12-months post index procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start11 Nov 2021
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Neuzil, MD, Principal investigator, Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113056
- Sponsor's protocol ID
- CLP-23
- Acronym
- PFA-AF
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
- ClinicalTrials.gov ID
- NCT05113056
- Acronym / sponsor ID
- PFA-AF / CLP-23
- Conditions
- Atrial Arrhythmia, Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, pulsed field ablation (PFA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Detailed description
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
| Arm | Type | Receives |
|---|---|---|
| Non-randomized | Experimental | Device: Acutus Medical Pulsed Field Ablation SystemAll subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 18 to 80 years at time of consent
- Clinically indicated and scheduled for a de novo catheter ablation of AF
- Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
Key exclusion criteria (20 listed)
- In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- Continuous episodes of AF duration lasting longer than 12-months
- Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- Structural heart disease or cardiac history as described below:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acutus Medical Pulsed Field Ablation SystemAll subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation. | Device | Non-randomized |
Primary outcome
Proportion of subjects who are free from device/procedure related Major Adverse Events
Time frame: 6 months
The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
Time frame: 20 minutes post ablation
The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device
2 secondary outcomes
Analysis of all identified SAEs, SADEs, and UADEs
Time frame: 12 months
Subjects with freedom from an atrial arrhythmia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Neuzil, MD principal investigator
Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acutus Medical Pulsed Field Ablation System in people with Atrial Arrhythmia and Atrial Fibrillation, run by Acutus Medical at 1 site 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 3 inclusion and 20 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects who are free from device/procedure related Major Adverse Events (time frame: 6 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?
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 13 Nov 2023.