Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Purpose
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Conditions
- Atrial Fibrillation (AF)
- Persistant Atrial Fibrillation
- Paroxysmal AF
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Non-randomized, multi-center
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
Grandview
Birmingham 4049979, Alabama 4829764 35243
Birmingham 4049979, Alabama 4829764 35243
Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
Jonesboro 4116834, Arkansas 4099753 72401
Emory
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Prairie Education & Research Cooperative
Springfield 4250542, Illinois 4896861 62769
Springfield 4250542, Illinois 4896861 62769
Kansas City Heart Rhythm Institute (KCHRI)
Overland Park 4276873, Kansas 4273857 66212
Overland Park 4276873, Kansas 4273857 66212
TriHealth Cincinnati
Cincinnati 4508722, Ohio 5165418 45202
Cincinnati 4508722, Ohio 5165418 45202
Trident Medical Center
Charleston 4574324, South Carolina 4597040 29406
Charleston 4574324, South Carolina 4597040 29406
Contact:
Franklin Cuoco, MD
Franklin Cuoco, MD
Texas Cardiac Arrhythmia Research Foundation
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78705
More Details
- Status
- Recruiting
- Sponsor
- Arga Medtech SA
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.