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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056328
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : May 23, 2014
Last Update Posted : February 26, 2019
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: SJM Irrigated Cardiac Ablation System Device: FDA approved Open Irrigated RF Ablation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Irrigated Ablation System Evaluation for AF
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: St. Jude Medical Cardiac Ablation System Device: SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter

Active Comparator: FDA approved Open Irrigated Radio Frequency Ablation System Device: FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter

Primary Outcome Measures :
  1. Confirmation of Entrance Block in the Pulmonary Veins [ Time Frame: 20 minutes after initial isolation ]
  2. 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.

  3. Incidence of Adverse Events Included in the Pre-specified Composite. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period [ Time Frame: 12 months ]
  2. Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs [ Time Frame: 12 months ]
    Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056328

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Sponsors and Collaborators
Abbott Medical Devices
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Responsible Party: Abbott Medical Devices Identifier: NCT01056328    
Other Study ID Numbers: 90030928
First Posted: January 26, 2010    Key Record Dates
Results First Posted: May 23, 2014
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes