RECRUITING

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

Conditions

Atrial Fibrillation (AF)Persistant Atrial Fibrillation Paroxysmal AF atrial fibrillation ablation coherent sine-burst electroporation pulsed field ablation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-09-10

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06784466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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).

Inclusion Criteria

Exclusion 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:
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.

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).

Contacts and Locations

Study Contact

Steven McQuillan, BA

CONTACT

1-763-331-4344

smcquillan@argamedtech.com

Deana Pierce, BS

CONTACT

1-760-637-9109

dpierce@argamedtech.com

Study Locations (Sites)

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705

United States

Collaborators and Investigators

Sponsor: Arga Medtech SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-10

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-09-10

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

atrial fibrillation
ablation
coherent sine-burst
electroporation
pulsed field ablation

Additional Relevant MeSH Terms

Atrial Fibrillation (AF)
Persistant Atrial Fibrillation
Paroxysmal AF