Clinical trial NCT01056328: Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
Official title: Irrigated Ablation System Evaluation for AF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Confirmation of Entrance Block in the Pulmonary Veins
timeFrame: 20 minutes after initial isolation
measure: Incidence of Adverse Events Included in the Pre-specified Composite
timeFrame: 7 days
measure: Incidence of Adverse Events Included in the Pre-specified Composite.
timeFrame: 12 months
Secondary outcomes:
measure: Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
timeFrame: 12 months
measure: Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants/Scottsdale Healthcare
state: Arizona
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: San Diego
country: United States
facility: University of Californai, San Diego Medical Center
state: California
city: Colorado Springs
country: United States
facility: Colorado Cardiac Alliance
state: Colorado
city: Jacksonville
country: United States
facility: Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Emory
country: United States
facility: Emory University Hospital, Midtown
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Kansas City
country: United States
facility: MAHI, Saint Luke's Hospital
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital / Inova Heart and Vascular Institute
state: Virginia
city: Toronto
country: Canada
facility: Sunybrook Health Sciences Centre
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: