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

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: SJM Irrigated Cardiac Ablation System; Device: FDA approved Open Irrigated RF Ablation System

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunybrook Health Sciences Centre
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
  • Seoul, Korea, Republic of, 136-705
    • Korea University Anam Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Arizona Arrhythmia Consultants/Scottsdale Healthcare
  • California
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • San Diego, California, United States, 92037
      • University of Californai, San Diego Medical Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Cardiac Alliance
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Emory, Georgia, United States, 30308
      • Emory University Hospital, Midtown
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • MAHI, Saint Luke's Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Austin, Texas, United States, 78746
      • Texas Cardiac Arrhythmia Research Foundation
    • Dallas, Texas, United States, 75226
      • Baylor Heart & Vascular Hospital
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
  • Utah
    • Salt Lake City, Utah, United States, 84157
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital / Inova Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of Entrance Block in the Pulmonary Veins		20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite	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.	7 days
Incidence of Adverse Events Included in the Pre-specified Composite.		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	12 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 22, 2010
• First Submitted That Met QC Criteria: January 22, 2010
• First Posted (Estimate): January 26, 2010

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 90030928