Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
NCT ID: NCT06784466
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
360 participants
INTERVENTIONAL
2025-09-10
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paroxysmal AF
Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Persistent AF
Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Interventions
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Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
80 Years
ALL
No
Sponsors
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Arga Medtech SA
INDUSTRY
Responsible Party
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Locations
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Grandview
Birmingham, Alabama, United States
Banner University Med Ctr
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
UCSD
San Diego, California, United States
Ascension / St. Vincent's Jacksonville
Jacksonville, Florida, United States
Emory
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Kansas City Heart Rhythm Institute (KCHRI)
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Michigan
Ann Arbor, Michigan, United States
TriHealth Cincinnati
Cincinnati, Ohio, United States
Trident Medical Center
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Methodist
San Antonio, Texas, United States
KBC Split
Split, , Croatia
KBC Zagreb
Zagreb, , Croatia
Neuron Medical s.r.o.
Brno, Czech Republic, Czechia
Institut klinické a experimentální medicíny (IKEM)
Prague, Czech Republic, Czechia
Nemocnice Na Homolce
Prague, , Czechia
Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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Anil Rajendra, MD
Role: primary
Susan Thorington
Role: backup
Rong Bai, MD
Role: primary
Stephanie Marsh
Role: backup
Devi Nair, MD
Role: primary
Chris Prather
Role: backup
Jonathan Hsu, MD
Role: primary
Jesus Gil
Role: backup
Saumil Oza, MD
Role: primary
Arianna Wright
Role: backup
David De Lurgio, MD
Role: primary
McKenzie Duncan
Role: backup
Alok Gambhir, MD
Role: primary
Gambhir
Role: backup
Ziad Issa, MD
Role: primary
Lauren McNeil
Role: backup
Dhanunjaya Lakkireddy, MD
Role: primary
Donita Atkins
Role: backup
Gery Tomassoni, MD
Role: primary
Franklin Echevarria Gonzalez
Role: backup
Michael Ghannam, MD
Role: primary
Kirsta Bray
Role: backup
Emile Daoud, MD
Role: primary
Tia Little
Role: backup
Franklin Cuoco, MD
Role: primary
Andrea Natale, MD
Role: primary
Deb Cardinal, RN
Role: backup
David Pederson, MD
Role: primary
Ante Anic, MD
Role: primary
Ante Borovina
Role: backup
Vedran Velagić, MD
Role: primary
Zvonimir Katic
Role: backup
Martin Fiala, MD
Role: primary
Simona Peřinková
Role: backup
Josef Kautzner, MD
Role: primary
Ivana Kuklova
Role: backup
Petr Neuzil, MD
Role: primary
Petr Moučka
Role: backup
Gediminas Rackauskas, MD
Role: primary
Kristina Scerbakovaite
Role: backup
Other Identifiers
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CIP-001
Identifier Type: -
Identifier Source: org_study_id