In This SectionTexas Health Research & Education Institute
Disease or Condition
Irrigated Ablation System Evaluation for AF
This study is for a new device that will contribute to the treatment of atrial fibrillation (AF) which is an irregular heartbeat.
Age 18 years or older.
Must be able to speak, read and write in English.
Signed Patient Informed Consent Form.
Able and willing to comply with all pre-. post-, and follow-up testing and requirements.
Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation:
[class I or III. or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation.
Or intolerable side effects due to AAD
Subjects with symptomatic paroxysmal atrial fibrillation who had 3 AF episodes in the 6 months prior to randomization. one of which was documented by electrocardiogram (ECG), transtelephonic monitor (TIM). Holter monitor, or telemetry strip.
AF secondary to electrolyte imbalance. thyroid disease. or reversible or non-cardiac cause.
Previous ablation for AF.
History of any valvular cardiac surgical procedure.
CABG procedure within the last six months.
Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
Left atrial thrombus.
History of a documented thromboembolic event within the past one (1) year.
Diagnosed atrial myxoma.
An implanted ICD.
Significant pulmonary disease. (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
Acute illness or active systemic infection or sepsis.
Myocardial infarction within the previous two months.
Left ventricular ejection fraction (L VEF) < 40% as determined by pre-procedure TTE.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e. heparin, diabigatran or warfarin).
Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure.
Life expectancy less than 12 months.
Enrollment in an investigational study evaluating another device or drug.
Uncontrolled heart failure or NYHA class III or IV heart failure.
An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation.
Presence of a condition that precludes vascular access.
Left atrial size = 50 mm as determined by pre-procedure TTE.