search
Back to results

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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SJM Irrigated Cardiac Ablation System
FDA approved Open Irrigated RF Ablation System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Arrhythmia Consultants/Scottsdale Healthcare
  • Good Samaritan Hospital
  • University of Californai, San Diego Medical Center
  • Colorado Cardiac Alliance
  • Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
  • Tampa General Hospital
  • Emory University Hospital, Midtown
  • University of Kansas Hospital
  • Washington Adventist Hospital
  • Spectrum Health
  • MAHI, Saint Luke's Hospital
  • NYU Langone Medical Center
  • Mount Sinai Hospital
  • University of Rochester
  • University Hospitals Case Medical Center
  • Cleveland Clinic
  • The Ohio State University Medical Center
  • Doylestown Hospital
  • Hospital of the University of Pennsylvania
  • Centennial Medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • Baylor Heart & Vascular Hospital
  • The Methodist Hospital Research Institute
  • Intermountain Medical Center
  • University of Virginia Health System
  • Inova Fairfax Hospital / Inova Heart and Vascular Institute
  • Sunybrook Health Sciences Centre
  • Severance Hospital
  • Korea University Anam Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

St. Jude Medical Cardiac Ablation System

FDA approved Open Irrigated Radio Frequency Ablation System

Arm Description

Outcomes

Primary Outcome Measures

Confirmation of Entrance Block in the Pulmonary Veins
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.
Incidence of Adverse Events Included in the Pre-specified Composite.

Secondary Outcome Measures

Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
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)

Full Information

First Posted
January 22, 2010
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT01056328
Brief Title
Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
Acronym
IRASE-AF
Official Title
Irrigated Ablation System Evaluation for AF
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
St. Jude Medical Cardiac Ablation System
Arm Type
Experimental
Arm Title
FDA approved Open Irrigated Radio Frequency Ablation System
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
SJM Irrigated Cardiac Ablation System
Intervention Description
Irrigated ablation catheter
Intervention Type
Device
Intervention Name(s)
FDA approved Open Irrigated RF Ablation System
Intervention Description
Irrigated ablation catheter
Primary Outcome Measure Information:
Title
Confirmation of Entrance Block in the Pulmonary Veins
Time Frame
20 minutes after initial isolation
Title
Incidence of Adverse Events Included in the Pre-specified Composite
Description
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.
Time Frame
7 days
Title
Incidence of Adverse Events Included in the Pre-specified Composite.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Time Frame
12 months
Title
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arrhythmia Consultants/Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
University of Californai, San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Colorado Cardiac Alliance
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital, Midtown
City
Emory
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
MAHI, Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital / Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sunybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

We'll reach out to this number within 24 hrs