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New heart zapping device could offer safer fix for irregular heartbeat

NCT ID NCT06784466

Disease control Sponsor: Arga Medtech SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This study tests a new device that uses short bursts of electricity to treat atrial fibrillation (AF), a common heart rhythm problem. About 360 adults with AF will receive the procedure to see if it safely restores a normal heartbeat. The goal is to improve symptoms and quality of life without long-term medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients between the ages of 18 and 80 years, or older than 18 if required by local law. 2. Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF: a. Symptomatic paroxysmal AF that is less than 7 days in continuous duration, documented by the following: i. Physician documentation of symptomatic recurrent PAF (2 or more episodes) within 6 months prior to enrollment AND ii. At least 1 documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment. b. Symptomatic persistent AF that is sustained beyond 7 days and less than 1 year (≥ 7 and ≤ 365 days), documented by the following: i. Physician documentation of at least 1 symptomatic persistent AF episode within 6 months prior to enrollment. ii. Either a 24-hour continuous ECG recording documenting continuous AF OR 2 ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart, within 6 months prior to enrollment. 3. Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug. 4. Willing and able to give informed consent. 5. Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study. 6. Life expectancy \>1 year. Exclusion Criteria: 1. In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial \[LA\] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation. 2. Any duration of continuous AF lasting longer than 12 months. 3. History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure. 4. AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause. 5. Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test). 6. New York Heart Association (NYHA) Class III or IV. 7. Left atrial diameter \> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \>100mL if left atrial diameter is not available. 8. Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable/insertable cardiac loop recorder/monitor at the time of the ablation procedure. 9. Body mass index (BMI) \>40. 10. Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure. 11. Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment. 12. Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s). 13. Presence of pulmonary vein abnormalities of stenosis or stenting. 14. Primary pulmonary hypertension. 15. Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline). 16. Pre-existing hemi-diaphragmatic paralysis. 17. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant. 18. Rheumatic heart disease. 19. Unstable angina or ongoing myocardial ischemia. 20. Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \>15mm). 21. History of blood clotting or bleeding disease (e.g., thrombocytosis). 22. History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment. 23. Active systemic infection. 24. Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma, or non-metastatic prostate or breast cancer with life expectancy remaining \>1 year). 25. Pregnant or lactating (current or anticipated during study follow-up). 26. Current enrollment in any other clinical study where testing or results from that study may interfere with the procedure or outcomes measurement for this study. 27. Any other condition that, in the judgment of the Investigator, makes the patient: 1. Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or 2. A poor candidate for the study (e.g., vulnerable patient population, mental illness, addictive disease, terminal illness, and extensive travel away from the research center).

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) Paroxysmal af Persistant atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZorg Aalst

    RECRUITING

    Aalst, 9300, Belgium

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Arrhythmia Research Group

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Ascension / St. Vincent's Jacksonville

    RECRUITING

    Jacksonville, Florida, 32204, United States

  • Banner University Med Ctr

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 30322, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Emory

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Grandview

    RECRUITING

    Birmingham, Alabama, 35243, United States

  • Institut klinické a experimentální medicíny (IKEM)

    RECRUITING

    Prague, Czech Republic, 140 21, Czechia

  • Jessa Ziekenhuis

    RECRUITING

    Hasselt, 3500, Belgium

  • KBC Split

    RECRUITING

    Split, HR 21000, Croatia

  • KBC Zagreb

    RECRUITING

    Zagreb, 10000, Croatia

  • Kansas City Heart Rhythm Institute (KCHRI)

    RECRUITING

    Overland Park, Kansas, 66212, United States

  • Methodist

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Motol and Homolka University Hospital

    RECRUITING

    Prague, 150 30, Czechia

  • Neuron Medical s.r.o.

    RECRUITING

    Brno, Czech Republic, 639 00, Czechia

  • Northside Hospital

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Ohio Health Research and Innovation Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Prairie Education & Research Cooperative

    RECRUITING

    Springfield, Illinois, 62769, United States

  • St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705, United States

  • TriHealth Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45202, United States

  • Trident Medical Center

    RECRUITING

    Charleston, South Carolina, 29406, United States

  • UCSD

    RECRUITING

    San Diego, California, 92037-7411, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vilnius University Hospital Santariskiu Klinikos

    RECRUITING

    Vilnius, LT-08406, Lithuania

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