Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Volta Medical
With
Fortrea
CardiaBase
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients 18 years of age or older candidates for a first AF ablation
Symptomatic AF, refractory to at least one antiarrhythmic medication
Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and \< 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \> 4 weeks prior to ablation
Patients must be able and willing to provide written informed consent to participate in the clinical trial
At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months
LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
Contraindications to anticoagulation (heparin, warfarin or NOAC)
Patients who are or may potentially be pregnant
Previous surgical or catheter ablation for AF
Any cardiac surgery within the past 2 months (60 days) (includes PCI)
Myocardial infarction within the past 2 months (60 days)
Previous atrioventricular valve surgery
History of blood clotting or bleeding abnormalities
Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
Rheumatic Heart Disease
Chronic severe Heart Failure (NYHA functional class IV and/or LVEF \< 25%)
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
Unstable angina within the past month
Acute illness or active systemic infection or sepsis
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Diagnosed atrial myxoma
Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Enrollment in an investigational study evaluating another device, biologic, or drug
Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
Life expectancy or other disease processes likely to limit survival to less than 12 months
Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
You may not be if
Paroxysmal and short-standing AF \< 3 months
Long-standing persistent AF \> 5 years (≥ 1 year in the United States)
≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
Severe obesity (BMI \> 40)
Very dilated Left Atrium (LA)(e.g. LA diameter \> 60 mm and/or LA surface \> 40 cm2 determined by 2D echocardiography)
Patients with AF secondary to an obvious reversible cause
