NCT01056328CompletedNot Applicable
Irrigated Ablation System Evaluation for AF
Abbott Medical Devices30 sites in 3 countries324 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 324
- Locations
- 30
- Primary Endpoint
- Confirmation of Entrance Block in the Pulmonary Veins
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
St. Jude Medical Cardiac Ablation System
Experimental
Intervention: SJM Irrigated Cardiac Ablation System (Device)
FDA approved Open Irrigated Radio Frequency Ablation System
Active Comparator
Intervention: FDA approved Open Irrigated RF Ablation System (Device)
Outcomes
Primary Outcomes
Confirmation of Entrance Block in the Pulmonary Veins
Time Frame: 20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite
Time Frame: 7 days
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
Incidence of Adverse Events Included in the Pre-specified Composite.
Time Frame: 12 months
Secondary Outcomes
- Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period(12 months)
- Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs(12 months)
Investigators
Study Sites (30)
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