AcQBlate Force Confirmatory Study for Atrial Arrhythmias

This is an interventional treatment trial for Atrial Arrhythmias focused on measuring ablation, atrial arrhythmia Read More

Inclusion Criteria:

• Male or female between the ages of 18 to 80 years at time of consent.
• Clinically indicated and scheduled for a de novo or repeat catheter ablation of PAF or PerAF
• Willing and able to provide written informed consent to to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.

Exclusion Criteria:

• In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications or sepsis
• Continuous AF > 12-months (long-standing persistent AF)
• Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
• An implanted pacemaker or Implantable Cardiac Defibrillator (ICD).
• Structural heart disease or cardiac history as described below:
• Left ventricular ejection fraction (LVEF) < 35% based on transthoracic echocardiogram (TTE) within the previous 180-days.
• Left atrial size > 55 mm based on TTE within the previous 180-days.
• Evidence of heart failure (NYHA Class III or IV).
• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for coronary artery bypass).
• Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve.
• Coronary artery bypass graft (CABG) or coronary angioplasty (PTCA) procedure within the last 90-days.
• Unstable angina or ongoing myocardial ischemia.
• Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg, diastolic pressure > 140 mm Hg recorded within the last 30-days.
• Moderate or severe tricuspid stenosis or regurgitation.
• Moderate or severe mitral stenosis or regurgitation.
• Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
• Presence of a left atrial appendage occlusion device.
• Previous PV stenting or evidence of PV stenosis
• Body Mass Index (BMI) >40 kg/m2
• History of blood clotting or bleeding disease.
• Any prior history of documented cerebral infarct or systemic embolism (excluding post- operative deep vein thrombosis (DVT)).
• Pregnant or lactating (current or anticipated during study follow up).
• Current enrollment in any other study protocol where testing or results from the study may interfere with the procedure or outcome measurements for this study.
• Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center)