Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT01056328
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-26
• Study Start: 2010-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2014-01-28
• Results First Submitted QC: 2014-04-28
• Results First Posted: 2014-05-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	12 months	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)

Trial Locations

Locations (30)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Arizona Arrhythmia Consultants/Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

University of Californai, San Diego Medical Center; 🇺🇸 San Diego, California, United States

Colorado Cardiac Alliance; 🇺🇸 Colorado Springs, Colorado, United States

Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital, Midtown; 🇺🇸 Emory, Georgia, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Washington Adventist Hospital; 🇺🇸 Takoma Park, Maryland, United States

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