BridgeMD
New treatment option for Atrial Fibrillation (AF)
Official title Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT06784466
What this study is testing
- What it's testing
- To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
- Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF: a. Symptomatic paroxysmal AF that is less than 7 days in continuous duration...
- how well it works failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
- Willing and able to give informed consent.
- Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
You likely can't join if
- In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial [LA] thrombus), trans-esophageal...
- Any duration of continuous AF lasting longer than 12 months.
- History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
- AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
- Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition...
- New York Heart Association (NYHA) Class III or IV.
See the full eligibility criteria
Who can join
- Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
- 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...
- how well it works failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
- Willing and able to give informed consent.
- Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
- Life expectancy \>1 year.
What rules you out
- 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.
- Any duration of continuous AF lasting longer than 12 months.
- History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
- AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
- 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).
- New York Heart Association (NYHA) Class III or IV.
- 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.
- 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...
- Body mass index (BMI) \>40.
- Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
- Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
- Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
- Presence of pulmonary vein abnormalities of stenosis or stenting.
- Primary pulmonary hypertension.
- Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline).
- Pre-existing hemi-diaphragmatic paralysis.
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73 m2, or any history of renal dialysis or renal transplant.
- Rheumatic heart disease.
- Unstable angina or ongoing myocardial ischemia.
- Hypertrophic cardiomyopathy, advanced restrictive cardiomyopathy, or severe left ventricular hypertrophy (left ventricular thickness \>15mm).
- History of blood clotting or bleeding disease (e.g., thrombocytosis).
- History of documented cerebral infarction, transient ischemic attack, or systemic embolism within 6 months prior to enrollment.
- Active systemic infection.
- 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...
- Pregnant or lactating (current or anticipated during study follow-up).
- 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.
- Any other condition that, in the judgment of the Investigator, makes the patient:
- Unlikely to benefit from an AF ablation procedure (e.g., advanced infiltrative cardiomyopathies, severe mitral stenosis or regurgitation, and/or cor pulmonale, etc.), or
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Jonesboro, Arkansas, United States
- San Diego, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Springfield, Illinois, United States
- Overland Park, Kansas, United States
- Lexington, Kentucky, United States
- Ann Arbor, Michigan, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Aalst, Belgium
- Hasselt, Belgium
- Split, Croatia
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Jonesboro, Arkansas, United States; San Diego, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.