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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

DEVICE

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

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

Locations (20)

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
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Health Research and Innovation Institute
Columbus, 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
AZorg Aalst
Aalst, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
KBC Split
Split, Croatia