Actively Recruiting
Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation
Led by Arga Medtech SA · Updated on 2026-06-05
360
Participants Needed
27
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System in treating patients with atrial fibrillation (AF), including both paroxysmal and persistent types. This prospective, multi-center, non-randomized study aims to provide clinical data to support regulatory approval of this device for AF ablation and additional atrial ablation when needed. The study focuses on patients with drug-refractory, recurrent, symptomatic AF who require pulmonary vein ablation. Participants will receive treatment using the Argá Medtech CSE Ablation System to isolate the pulmonary veins, with separate groups for paroxysmal and persistent AF patients. The ablation procedure is delivered using this device, and the study does not involve randomization or blinding. The study will follow patients for up to 12 months to assess treatment success and observe safety outcomes. During the study, participants will undergo baseline assessments, rhythm monitoring, and follow-up visits for up to one year. Researchers will measure safety by tracking any primary safety events up to 180 days after treatment and effectiveness by noting treatment success up to 12 months. Quality of life will also be evaluated using specific questionnaires. Participants must commit to all study visits and monitoring procedures throughout the study period to help assess the device's performance and safety.
CONDITIONS
Brief Title
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years or older if allowed by local law
- Diagnosis of drug-refractory, recurrent, symptomatic paroxysmal AF with episodes less than 7 days
- Diagnosis of symptomatic persistent AF lasting between 7 days and 1 year
- Documentation of AF episodes within 6 to 12 months prior to enrollment
- Failure, intolerance, or contraindication to at least one Class I or III anti-arrhythmic drug
- Willing and able to provide informed consent
- Commitment to participate in all baseline, follow-up, and rhythm monitoring evaluations
- Life expectancy greater than 1 year
You will not qualify if you...
- Contraindications to AF ablation, trans-esophageal echocardiogram, CT scan, or anticoagulation
- Continuous AF lasting longer than 12 months
- History of previous left atrial ablation or heart surgery
- AF caused by reversible or non-cardiac conditions such as electrolyte imbalance or thyroid disease
- Left ventricular ejection fraction below 35% within 6 months
- New York Heart Association Class III or IV heart failure
- Left atrial diameter greater than 5.0 cm or volume over 100 mL
- Planned or current cardiac implant devices at the time of ablation
- Body mass index over 40
- Lack of anticoagulation therapy for at least 3 weeks before procedure
- Recent cardiac surgery or interventions within 3 months
- Symptomatic valvular disease or prosthetic heart valves
- Pulmonary vein abnormalities
- Primary pulmonary hypertension
- Uncontrolled hypertension at baseline
- Pre-existing hemi-diaphragmatic paralysis
- Renal insufficiency with low filtration rate or history of dialysis or transplant
- Rheumatic heart disease
- Unstable angina or ongoing myocardial ischemia
- Severe cardiomyopathies or ventricular hypertrophy
- History of blood clotting or bleeding disorders
- Recent stroke, transient ischemic attack, or embolism within 6 months
- Active systemic infection or malignancy within 12 months
- Pregnant or lactating women
- Participation in other interfering clinical studies
- Other conditions making the patient unlikely to benefit or poor candidate per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive treatment with the Argá Medtech Coherent Sine-Burst Electroporation Ablation System to achieve pulmonary vein isolation for atrial fibrillation.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and effectiveness of the treatment for up to 12 months after the ablation procedure.
Approximately 6 follow-up visits over 12 months
Trial Site Locations
Total: 27 locations
1
Grandview
Birmingham, Alabama, United States, 35243
Actively Recruiting
2
Banner University Med Ctr
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
3
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
4
UCSD
San Diego, California, United States, 92037-7411
Actively Recruiting
5
Ascension / St. Vincent's Jacksonville
Jacksonville, Florida, United States, 32204
Actively Recruiting
6
Advent Health
Orlando, Florida, United States, 32803
Actively Recruiting
7
Emory
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
9
Prairie Education & Research Cooperative
Springfield, Illinois, United States, 62769
Actively Recruiting
10
Kansas City Heart Rhythm Institute (KCHRI)
Overland Park, Kansas, United States, 66212
Actively Recruiting
11
Baptist Health Lexington
Lexington, Kentucky, United States, 30322
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
TriHealth Cincinnati
Cincinnati, Ohio, United States, 45202
Actively Recruiting
14
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Ohio Health Research and Innovation Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
16
Trident Medical Center
Charleston, South Carolina, United States, 29406
Actively Recruiting
17
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
18
Methodist
San Antonio, Texas, United States, 78229
Actively Recruiting
19
AZorg Aalst
Aalst, Belgium, 9300
Actively Recruiting
20
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
21
KBC Split
Split, Croatia, HR 21000
Actively Recruiting
22
KBC Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
23
Neuron Medical s.r.o.
Brno, Czech Republic, Czechia, 639 00
Actively Recruiting
24
Institut klinické a experimentální medicíny (IKEM)
Prague, Czech Republic, Czechia, 140 21
Actively Recruiting
25
Motol and Homolka University Hospital
Prague, Czechia, 150 30
Actively Recruiting
26
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, LT-08406
Actively Recruiting
27
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Actively Recruiting
Research Team
S
Steven McQuillan, BA
D
Deana Pierce, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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