Irrigated Ablation System Evaluation for Atrial Fibrillation (AF) (IRASE-AF)

Abbott

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: SJM Irrigated Cardiac Ablation System; Device: FDA approved Open Irrigated RF Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056328

90030928

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older

• 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 (PAF)*

  • PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion criteria

• Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous ablation for AF
• History of any valvular cardiac surgical procedure
• Coronary artery bypass grafting (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 implantable cardioverter defibrillator (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
• Unstable angina
• Myocardial infarction within the previous two months
• Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation (i.e. heparin 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 New York Heart Association (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 2 patient groups

St. Jude Medical Cardiac Ablation System

Experimental group

Treatment:

Device: SJM Irrigated Cardiac Ablation System

FDA approved Open Irrigated Radio Frequency Ablation System

Active Comparator group

Treatment:

Device: FDA approved Open Irrigated RF Ablation System