Actively Recruiting
Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Led by Arga Medtech SA · Updated on 2026-04-08
360
Participants Needed
27
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
CONDITIONS
Official 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 between the ages of 18 and 80 years, or older than 18 if required by local law
- Diagnosis of drug refractory, recurrent, symptomatic paroxysmal AF less than 7 days in continuous duration with at least two episodes in 6 months and one documented episode within 12 months
- Diagnosis of symptomatic persistent AF lasting between 7 days and 1 year with at least one episode in 6 months and continuous AF documented by ECG recordings
- Effectiveness failure of, intolerance to, or contraindication to at least one Class I or III anti-arrhythmic drug
- Willing and able to give informed consent
- Commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full study length
- Life expectancy greater than 1 year
You will not qualify if you...
- Known contraindications to AF ablation, trans-esophageal echocardiogram, CT scan, or anticoagulation
- Continuous AF lasting longer than 12 months
- Previous left atrial ablation or surgical procedure, including prior left atrial appendage closure
- AF caused by electrolyte imbalance, thyroid disease, alcohol, or reversible/non-cardiac causes
- Left ventricular ejection fraction less than 35% within 6 months
- New York Heart Association Class III or IV heart failure
- Left atrial diameter greater than 5.0 cm or non-indexed volume over 100 mL within 6 months
- Current or planned implant of certain cardiac devices at time of ablation
- Body mass index over 40
- No anticoagulation therapy for at least 3 weeks before the procedure
- Recent cardiac surgery, myocardial infarction, PCI, or stenting within 3 months
- Symptomatic valvular disease or history of valve surgery
- Pulmonary vein abnormalities such as stenosis or stenting
- Primary pulmonary hypertension
- Uncontrolled or untreated hypertension with high blood pressure readings at baseline
- Pre-existing hemi-diaphragmatic paralysis
- Renal insufficiency with low eGFR or history of dialysis or transplant
- Rheumatic heart disease
- Unstable angina or ongoing myocardial ischemia
- Certain cardiomyopathies or severe left ventricular hypertrophy
- History of blood clotting or bleeding disorders
- Recent cerebral infarction, transient ischemic attack, or systemic embolism within 6 months
- Active systemic infection
- Active malignancy or recent treated malignancy within 12 months except certain skin and non-metastatic cancers
- Pregnant or lactating women
- Enrollment in another clinical study that may interfere with this study
- Any condition making the patient unlikely to benefit or a poor candidate as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not Yet 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
CONTACT
D
Deana Pierce, BS
CONTACT
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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