Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

Paroxysmal Atrial Fibrillation Clinical Trial

— IRASE-AF  

Official title:

Irrigated Ablation System Evaluation for AF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056328
• Other study ID #: 90030928
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
• FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter

Locations

Country	Name	City	State
Canada	Sunybrook Health Sciences Centre	Toronto	Ontario
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Colorado Cardiac Alliance	Colorado Springs	Colorado
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Emory University Hospital, Midtown	Emory	Georgia
United States	Inova Fairfax Hospital / Inova Heart and Vascular Institute	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center	Jacksonville	Florida
United States	MAHI, Saint Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Good Samaritan Hospital	Los Angeles	California
United States	Centennial Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	University of Californai, San Diego Medical Center	San Diego	California
United States	Arizona Arrhythmia Consultants/Scottsdale Healthcare	Scottsdale	Arizona
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of Entrance Block in the Pulmonary Veins		20 minutes after initial isolation
Primary	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
Primary	Incidence of Adverse Events Included in the Pre-specified Composite.		12 months
Secondary	Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period		12 months
Secondary	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