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Atrial Fibrillation (AF)COHERENT-AFNCT06784466

Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

A study testing Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System in people with Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, run by Arga Medtech SA at 27 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
27 sitesin 6 countries
Study dates
10 Sep 2025to Aug 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

  • Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
  • Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
  • 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.
  • 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.
  • 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.
  • Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
Show all 9Show fewer
  • Willing and able to give informed consent.
  • Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
  • Life expectancy >1 year.

Who cannot join

  • 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.
  • Any duration of continuous AF lasting longer than 12 months.
  • History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
  • AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
  • 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).
  • New York Heart Association (NYHA) Class III or IV.
Show all 29Show fewer
  • 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.
  • 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.
  • Body mass index (BMI) >40.
  • Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
  • Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
  • Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
  • Presence of pulmonary vein abnormalities of stenosis or stenting.
  • Primary pulmonary hypertension.
  • Uncontrolled or untreated hypertension (two measurements of >180mmHg systolic or >110 mmHg diastolic at baseline).
  • Pre-existing hemi-diaphragmatic paralysis.
  • Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant.
  • Rheumatic heart disease.
  • Unstable angina or ongoing myocardial ischemia.
  • Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness >15mm).
  • History of blood clotting or bleeding disease (e.g., thrombocytosis).
  • History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.
  • Active systemic infection.
  • 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).
  • Pregnant or lactating (current or anticipated during study follow-up).
  • 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.
  • Any other condition that, in the judgment of the Investigator, makes the patient:
  • Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or
  • 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).

Trial locations and contacts

27 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Steven McQuillan, BA contact

1-763-331-4344

smcquillan@argamedtech.com

Deana Pierce, BS contact

1-760-637-9109

dpierce@argamedtech.com

27 sites in 6 countries

United States18 sites, 18 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Michael Ghannam, MD, mousajab@med.umich.edu

    Kirsta Bray, kibray@med.umich.edu

    Recruiting

  • Emory

    Atlanta, Georgia, 30322

    David De Lurgio, MD, 404-251-1481, ddelurg@emory.edu

    McKenzie Duncan, 404-686-7450, mtdunca@emory.edu

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Alok Gambhir, MD, Alok.Gambhir@northside.com

    Gambhir

    Recruiting

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

    Andrea Natale, MD, 512-657-0046, Andrea.Natale@hcahealthcare.com

    Deb Cardinal, RN, (512) 522-9410, dscardinal@austinheartbeat.com

    Recruiting

  • Grandview

    Birmingham, Alabama, 35243

    Anil Rajendra, MD, anil.rajendra@gmail.com

    Susan Thorington, 205-971-7578, susan.thorington@grandviewhealth.com

    Recruiting

  • Trident Medical Center

    Charleston, South Carolina, 29406

    Franklin Cuoco, MD

    Franklin Cuoco, MD

    Recruiting

  • TriHealth Cincinnati

    Cincinnati, Ohio, 45202

    Emile Daoud, MD, emiledaoud10@gmail.com

    Tia Little, Tia_little@trihealth.com

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Walid Saliba, MD, SALIBAW@ccf.org

    Andrew Burns, 440-637-1275, BURNSA9@ccf.org

    Recruiting

  • Ohio Health Research and Innovation Institute

    Columbus, Ohio, 43214

    Anish Amin, MD, Anish.amin@ohiohealth.com

    Steven Neville, 614-566-1266, Steven.Neville@ohiohealth.com

    Recruiting

  • Ascension / St. Vincent's Jacksonville

    Jacksonville, Florida, 32204

    Saumil Oza, MD, Saumil.oza@ascension.org

    Arianna Wright, Arianna.wright@ascension.org

    Recruiting

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

    Devi Nair, MD, drdevignair@gmail.com

    Chris Prather, cprather@dnairresearch.com

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 30322

    Gery Tomassoni, MD, Gery.Tomassoni@BHSI.com

    Franklin Echevarria Gonzalez, Franklin.EchevarriaGonzalez@bhsi.com

    Recruiting

  • Advent Health

    Orlando, Florida, 32803

    Naushad Shaik, MD, 407-303-5600, shaiknaushad@me.com

    Omar Marquez, 407-303-7556, Omar.Marquez@adventhealth.com

    Recruiting

  • Kansas City Heart Rhythm Institute (KCHRI)

    Overland Park, Kansas, 66212

    Dhanunjaya Lakkireddy, MD, dlakkireddy@gmail.com

    Donita Atkins, 816-651-1969, donita.atkins@hcahealthcare.com

    Recruiting

  • Banner University Med Ctr

    Phoenix, Arizona, 85006

    Rong Bai, MD, rong.bai@bannerhealth.com

    Stephanie Marsh, slmarsh@arizona.edu

    Recruiting

  • Methodist

    San Antonio, Texas, 78229

    David Pederson, MD, epdocdp@gmail.com

    David Pederson, MD

    Recruiting

  • UCSD

    San Diego, California, 92037-7411

    Jonathan Hsu, MD, Jonathan.Hsu@health.ucsd.edu

    Jesus Gil, jegil@health.ucsd.edu

    Recruiting

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62769

    Ziad Issa, MD, ziad.issa@prairieheart.com

    Lauren McNeil, lmcneil@prairieresearch.com

    Recruiting

Other trials in United States

Czechia3 sites, 3 recruiting

  • Neuron Medical s.r.o.

    Brno, Czech Republic, 639 00

    Martin Fiala, MD, martin.fiala@neuronmedical.cz

    Simona Peřinková, simona.perinkova@neuronmedical.cz

    Recruiting

  • Institut klinické a experimentální medicíny (IKEM)

    Prague, Czech Republic, 140 21

    Josef Kautzner, MD, josef.kautzner@ikem.cz

    Ivana Kuklova, +420733677694, kuki@ikem.cz

    Recruiting

  • Motol and Homolka University Hospital

    Prague, 150 30

    Petr Neuzil, MD, +420 603 440 254, PNeuzil@seznam.cz

    Petr Moučka, +420 605 316 001, Petr.Moucka@homolka.cz

    Recruiting

Other trials in Czechia

Belgium2 sites, 2 recruiting

  • AZorg Aalst

    Aalst, 9300

    Tom De Potter, MD, tom.de.potter@azorg.be

    Hedwig Batjoens, hedwig.batjoens@azorg.be

    Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500

    Johan Vijgen, MD, johan.vijgen@jessazh.be

    Johan Vijgen, MD

    Recruiting

Other trials in Belgium

Croatia2 sites, 2 recruiting

  • KBC Split

    Split, HR 21000

    Ante Anic, MD, +385 21 557 111, anteanic@gmail.com

    Ante Borovina, +385 95 798 9386, anteborovina80@gmail.com

    Recruiting

  • KBC Zagreb

    Zagreb, 10000

    Vedran Velagić, MD, vvelagic@gmail.com

    Zvonimir Katic, katiczvone3@gmail.com

    Recruiting

Other trials in Croatia

Lithuania1 site, 1 recruiting

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, LT-08406

    Gediminas Rackauskas, MD, gediminas.rackauskas@santa.lt

    Kristina Scerbakovaite, Kristina.Scerbakovaite@santa.lt

    Recruiting

Other trials in Lithuania

Netherlands1 site, 1 recruiting

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

    Lucas Boersma, MD, +31 3060933637, l.boersma@antoniusziekenhuis.nl

    Marjon Vissers-Fris, m.vissers@antoniusziekenhuis.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Read the detailed description

A prospective, multi-center, non-randomized, unblinded pre-market study designed to provide clinical data to support regulatory approval of the Argá Medtech CSE Ablation System for the ablation of atrial fibrillation and adjunctive use for additional atrial ablation. Patients with a history of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) will, at a minimum, undergo ablative intervention of the pulmonary veins.

Being tested
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Keywords
atrial fibrillation, ablation, coherent sine-burst, electroporation, pulsed 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.

  • Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation SystemDevice

    Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Study groups in NCT06784466
Study groupRoleWhat they receive
Paroxysmal AFExperimentalPatients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Receives: Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Persistent AFExperimentalPatients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Receives: Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

What is being measured

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

  1. Safety: Number of Participants With at Least One Primary Safety Event.

    Primary safety events are:

    Within 7 days of the index procedure:

    • Complete heart block
    • Coronary spasm
    • Myocardial infarction
    • Peripheral or organ thromboembolism
    • Stroke
    • Transient ischemic attack
    • Unresolved phrenic nerve palsy
    • Vascular access complications
    • Pericarditis

    Within 30 days of the index procedure:

    • Acute renal failure
    • Cardiac tamponade / perforation
    • Cardiovascular or pulmonary Pulsed Field Ablation (PFA)-related hospitalization
    • Death
    • Gastroparesis
    • Major bleeding

    Within180 days of the index procedure:

    • Pulmonary vein stenosis (≥70% diameter reduction)
    • Esophageal perforating complications

    Measured: Up to 180 days

  2. Effectiveness: Number of Participants With Treatment Success.

    Treatment success is defined as freedom from treatment failure.

    1. Acute Procedural Success and
    2. Chronic Success:
    • Documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) on a 12-lead electrocardiogram (ECG), event monitor, or Holter monitor after the 90-day Blanking Period
    • Re-ablation in the left atrium for AF, AFL, or AT
    • Any electrical cardioversion for AF, AFL, or AT
    • Any Class I or III antiarrhythmic (AAD) dose increase from the historic maximum ineffective dose prior to the Index Procedure or initiation of any new Class I or III AAD.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Quality of Life - Change in EQ-5D-3L Score

    Change in EQ-5D-3L score (12-month score - baseline score). The Euroqol EQ-5D-3L questionnaire (3L version) is a standardized instrument for measuring general health status. The Euroqol EQ-5D-3L questionnaire (which consists of a 5-question survey and a visual analog scale) has a composite score based on the 5-question survey that ranges from 0 (least healthy) to 1 (most healthy).

    Measured: Baseline to 12 months post-ablation

  2. Quality of Life - Change in The AF Effect on Quality-of-Life questionnaire (AFEQT) Score

    Change in AFEQT score (12-month score - baseline score). The AFEQT questionnaire is an atrial fibrillation (AF) specific health-related quality of life questionnaire to assess the impact of AF on a subject's life. The overall score ranges from 0 - 100, with 0 corresponding to complete disability and 100 corresponding to no disability.

    Measured: Baseline to 12 months post-ablation

Timeline

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

  1. First posted20 Jan 2025
  2. Study start10 Sep 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionAug 2027 (estimated)

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
Non-randomised
Intervention model
Single group
Model description
Non-randomized, multi-center
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784466
Sponsor's protocol ID
CIP-001
Acronym
COHERENT-AF
Status last verified
Jul 2026
First submitted
9 Jan 2025
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: data will be published in aggregate

Questions about this trial

What is this clinical trial studying?

A study testing Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System in people with Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, run by Arga Medtech SA at 27 sites in 6 countries.

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 9 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Czechia, Belgium, Croatia, Lithuania and 1 more country. 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?

Contact Steven McQuillan, BA (1-763-331-4344, smcquillan@argamedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Number of Participants With at Least One Primary Safety Event. (time frame: Up to 180 days). 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 NCT06784466.

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 15 Jul 2026.

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