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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01056328
First received: January 22, 2010
Last updated: April 28, 2014
Last verified: April 2014

January 22, 2010
April 28, 2014
February 2010
January 2013   (final data collection date for primary outcome measure)
  • Confirmation of Entrance Block in the Pulmonary Veins [ Time Frame: 20 minutes after initial isolation ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events Included in the Pre-specified Composite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Confirmation of entrance block in the pulmonary veins [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Incidence of adverse events included in the pre-specified composite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events Included in the Pre-specified Composite. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Freedom from symptomatic AF during nine months following the blanking period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01056328 on ClinicalTrials.gov Archive Site
  • Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)
  • Documented (> 30 seconds) asymptomatic episodes of AF, AFL or AT after the blanking period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Early onset (within 90 days) of SAE/Non-serious AEs and late onset (after 90 days) SAEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
Irrigated Ablation System Evaluation for AF

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • Device: SJM Irrigated Cardiac Ablation System
    Irrigated ablation catheter
  • Device: FDA approved Open Irrigated RF Ablation System
    Irrigated ablation catheter
  • Experimental: St. Jude Medical Cardiac Ablation System
    Intervention: Device: SJM Irrigated Cardiac Ablation System
  • Active Comparator: FDA approved Open Irrigated Radio Frequency Ablation System
    Intervention: Device: FDA approved Open Irrigated RF Ablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Korea, Republic of
 
NCT01056328
90030928
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP