Atrial ArrhythmiasNCT06452589
The Field PULSE Study
A study testing FieldForce Ablation System in people with Atrial Arrhythmias, run by Field Medical at 1 site in Czechia.
Trial summary
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Arrhythmias
- What is being tested?
- FieldForce Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed patient informed consent form (ICF).
- Female and male patients aged ≥ 18 and ≤ 80.
- Documented atrial fibrillation via an electrocardiogram (must be at least 30 seconds) within one year of enrollment.
- Indicated for a first-time catheter ablation for atrial fibrillation or associated atrial arrhythmias (European guidelines).
Who cannot join
- Body Mass Index > 40.
- Ineligible for ablation (including but not limited to known left atrial thrombus).
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible/non-cardiac causes.
- Previous endocardial/epicardial ablation or surgery for AF.
- NYHA Class IV.
- Left atrial appendage device or occlusion within 180 days.
Show all 24Show fewer
- Atrial or ventricular septal defect closure.
- Atrial myxoma.
- The presence of inferior vena cava embolic protection filter devices.
- Significant or symptomatic untreated hypotension, bradycardia, or chronotropic incompetence.
- History of hemodynamically severe valvular disease. Severity should be assessed using echocardiography, according to AHA and European guidelines.
- Diagnosis of pacemaker dependance.
- Uncontrolled abnormal bleeding and/or clotting disorder.
- Contraindication to systemic or oral anticoagulation.
- Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment of therapy, or confound data or its interpretation, including but not limited to solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
- History of severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea which may interfere with the assessment of the therapy.
- Active malignancy.
- Uncontrolled clinically significant infection.
- Life expectancy is less than one year.
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
- Any of the following within 3 months of enrollment: myocardial infarction, unstable angina, percutaneous coronary intervention, heart surgery (coronary artery bypass grafting/atriotomy), stroke or transient ischemic attack (TIA);
- Participation in another investigational study that would interfere with this study.
- Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
- Women who are of childbearing age and not on a reliable form of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Patients With Atrial Fibrillation
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.
Read the detailed description
Atrial fibrillation (AF) is a cardiac rhythm disorder characterized by irregular and often abnormally fast contractions of the atrial cardiomyocytes resulting in various symptoms, including palpitations, dizziness, shortness of breath and tiredness.
AF is the most common sustained cardiac arrhythmia, having a prevalence of about ≈2% in the general population. AF can be associated with increased morbidity and mortality in patients with cardiovascular disease, and increased risk of stroke in general population.
Catheter ablation for the treatment of AF is primarily performed with radiofrequency (RF) or cryoballoon (CB) catheters to achieve anatomic pulmonary vein isolation (PVI). However, the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB.
Pulsed field ablation (PFA) is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues. This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents, culminating in cell death. Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner.
The FieldForce™ Ablation System utilizes PFA with an innovative electrode technology called FieldBending™ designed to improve safety, tolerability, and efficacy for focal deflectable catheters used for the treatment of AF.
- Conditions
- Atrial Arrhythmias
- Being tested
- FieldForce Ablation System
- Keywords
- atrial arrhythmia, atrial fibrillation, PFA, Pulse Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FieldForce Ablation SystemDevice
Also called Pulse Field Ablation
The FieldForce Ablation System is indicated for cardiac electrophysiologic mapping, delivery of diagnostic pacing stimuli, and pulse field ablation of cardiac tissue. When used with the FieldForce Ablation Catheter, the FieldForce System is intended to be used in the right/left atria and/or left/right ventricle to deliver PFA ablation lesions in the selected areas of the chamber.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation | Experimental | Adult patients with a history of atrial fibrillation or associated atrial arrhythmias and indicated for a catheter ablation. Receives: Device: FieldForce Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early and late onset adverse events
Adverse events to evaluate the safety of the FieldForce™ Ablation System will be collected. The incidence of the major safety events will be evaluated.
Measured: 30 days and 12 months
Performance
To characterize the proportion of subjects who achieved pulmonary vein isolation (PVI) using the FieldForce™ Ablation System
Measured: index procedure and 3 months
Secondary outcomes (3)
Device or Procedure Related SAEs
Proportion of subjects reporting one or more device-or procedure-related SAEs.
Measured: 30 days, 3 months, 6 months and 12 months
Presence of Atrial Arrhythmias from index procedure through end of study
To evaluate freedom from atrial arrhythmia (including atrial fibrillation, flutter, or tachycardia).
Measured: 6 months and 12 months
Procedure Time
To characterize procedure times (including total duration, transpired ablation time, fluoroscopy time).
Measured: Index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start25 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial ArrhythmiasStudies 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
- Prospective single arm safety and feasibility study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Field Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452589
- Sponsor's protocol ID
- CLN-PULSE-PR-01
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Reddy VY, Petru J, Koruth JS, Funasako M, Skoda J, Salas JA, Mickelsen SR, Neuzil P. High-Voltage Focal PFA Catheter for "Instant" Point-By-Point Ablation: The First-In-Human FIELD-PULSE Trial to Treat AF. JACC Clin Electrophysiol. 2026 Sep 9:S2405-500X(26)00857-1. doi: 10.1016/j.jacep.2026.09.001. Online ahead of print.
PubMed 42714369
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06452589
- Acronym / sponsor ID
- CLN-PULSE-PR-01
- Conditions
- Atrial Arrhythmias
- Keywords
- atrial arrhythmia, atrial fibrillation, PFA, Pulse Field Ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Field MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2024 (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.
This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.
Detailed description
Atrial fibrillation (AF) is a cardiac rhythm disorder characterized by irregular and often abnormally fast contractions of the atrial cardiomyocytes resulting in various symptoms, including palpitations, dizziness, shortness of breath and tiredness.
AF is the most common sustained cardiac arrhythmia, having a prevalence of about ≈2% in the general population. AF can be associated with increased morbidity and mortality in patients with cardiovascular disease, and increased risk of stroke in general population.
Catheter ablation for the treatment of AF is primarily performed with radiofrequency (RF) or cryoballoon (CB) catheters to achieve anatomic pulmonary vein isolation (PVI). However, the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB.
Pulsed field ablation (PFA) is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues. This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents, culminating in cell death. Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner.
The FieldForce™ Ablation System utilizes PFA with an innovative electrode technology called FieldBending™ designed to improve safety, tolerability, and efficacy for focal deflectable catheters used for the treatment of AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm safety and feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Experimental | Device: FieldForce Ablation SystemAdult patients with a history of atrial fibrillation or associated atrial arrhythmias and indicated for a catheter ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed patient informed consent form (ICF).
- Female and male patients aged ≥ 18 and ≤ 80.
- Documented atrial fibrillation via an electrocardiogram (must be at least 30 seconds) within one year of enrollment.
- Indicated for a first-time catheter ablation for atrial fibrillation or associated atrial arrhythmias (European guidelines).
Key exclusion criteria (24 listed)
- Body Mass Index > 40.
- Ineligible for ablation (including but not limited to known left atrial thrombus).
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible/non-cardiac causes.
- Previous endocardial/epicardial ablation or surgery for AF.
- NYHA Class IV.
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 |
|---|---|---|
| FieldForce Ablation SystemAlso: Pulse Field AblationThe FieldForce Ablation System is indicated for cardiac electrophysiologic mapping, delivery of diagnostic pacing stimuli, and pulse field ablation of cardiac tissue. When used with the FieldForce Ablation Catheter, the FieldForce System is intended to be used in the right/left atria and/or left/right ventricle to deliver PFA ablation lesions in the selected areas of the chamber. | Device | Catheter ablation |
Primary outcome
Incidence of early and late onset adverse events
Time frame: 30 days and 12 months
Adverse events to evaluate the safety of the FieldForce™ Ablation System will be collected. The incidence of the major safety events will be evaluated.
Performance
Time frame: index procedure and 3 months
To characterize the proportion of subjects who achieved pulmonary vein isolation (PVI) using the FieldForce™ Ablation System
3 secondary outcomes
Device or Procedure Related SAEs
Time frame: 30 days, 3 months, 6 months and 12 months
Presence of Atrial Arrhythmias from index procedure through end of study
Time frame: 6 months and 12 months
Procedure Time
Time frame: Index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 42714369Reddy VY, Petru J, Koruth JS, Funasako M, Skoda J, Salas JA, Mickelsen SR, Neuzil P. High-Voltage Focal PFA Catheter for "Instant" Point-By-Point Ablation: The First-In-Human FIELD-PULSE Trial to Treat AF. JACC Clin Electrophysiol. 2026 Sep 9:S2405-500X(26)00857-1. doi: 10.1016/j.jacep.2026.09.001. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FieldForce Ablation System in people with Atrial Arrhythmias, run by Field 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 4 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of early and late onset adverse events (time frame: 30 days and 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 NCT06452589, which also lists 1 linked publication.
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 14 May 2026.