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

April 7, 2026 updated by: Arga Medtech SA

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis
        • Principal Investigator:
          • Johan Vijgen, MD
        • Contact:
  • Croatia
      • Split, Croatia, HR 21000
        • Recruiting
        • KBC Split
        • Principal Investigator:
          • Ante Anic, MD
        • Contact:
        • Contact:
      • Zagreb, Croatia, 10000
  • Czechia
      • Prague, Czechia, 150 30
        • Recruiting
        • Motol and Homolka University Hospital
        • Principal Investigator:
          • Petr Neuzil, MD
        • Contact:
        • Contact:
    • Czech Republic
      • Brno, Czech Republic, Czechia, 639 00
      • Prague, Czech Republic, Czechia, 140 21
        • Recruiting
        • Institut klinicke a experimentalni mediciny (IKEM)
        • Contact:
        • Principal Investigator:
          • Josef Kautzner, MD
        • Contact:
          • Ivana Kuklova
          • Phone Number: +420733677694
          • Email: kuki@ikem.cz
  • Lithuania
  • Netherlands
  • United States
    • Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Arkansas
    • California
    • Florida
      • Jacksonville, Florida, United States, 32204
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Principal Investigator:
          • Alok Gambhir, MD
        • Contact:
        • Contact:
          • Gambhir
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory
        • Principal Investigator:
          • David De Lurgio, MD
        • Contact:
        • Contact:
    • Illinois
    • Kansas
      • Overland Park, Kansas, United States, 66212
    • Kentucky
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Ohio
      • Cincinnati, Ohio, United States, 45202
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Walid Saliba, MD
        • Contact:
        • Contact:
      • Columbus, Ohio, United States, 43214
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Trident Medical Center
        • Contact:
          • Franklin Cuoco, MD
        • Principal Investigator:
          • Franklin Cuoco, MD
    • Texas
      • Austin, Texas, United States, 78705
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist
        • Contact:
        • Principal Investigator:
          • David Pederson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paroxysmal AF
Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Experimental: Persistent AF
Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Number of Participants With at Least One Primary Safety Event.
Time Frame: Up to 180 days

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
Up to 180 days
Effectiveness: Number of Participants With Treatment Success.
Time Frame: Up to 12 months

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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - Change in EQ-5D-3L Score
Time Frame: Baseline to 12 months post-ablation
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).
Baseline to 12 months post-ablation
Quality of Life - Change in The AF Effect on Quality-of-Life questionnaire (AFEQT) Score
Time Frame: Baseline to 12 months post-ablation
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.
Baseline to 12 months post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arga Medtech SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will be published in aggregate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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