Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

NCT01056328 | Completed Results DMC

• 1 other identifier: 90030928
• Study Type: interventional
• Target: 324
• Locations: 3 countries
• Sites: 30

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

St. Jude Medical Cardiac Ablation System

EXPERIMENTAL

Device: SJM Irrigated Cardiac Ablation System

FDA approved Open Irrigated Radio Frequency Ablation System

ACTIVE COMPARATOR

Device: FDA approved Open Irrigated RF Ablation System

Interventions

SJM Irrigated Cardiac Ablation System DEVICE

Irrigated ablation catheter

St. Jude Medical Cardiac Ablation System

FDA approved Open Irrigated RF Ablation System DEVICE

Irrigated ablation catheter

FDA approved Open Irrigated Radio Frequency Ablation System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (30)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Arrhythmia Consultants/Scottsdale Healthcare

Scottsdale, Arizona, 85251, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

University of Californai, San Diego Medical Center

San Diego, California, 92037, United States

Location

Colorado Cardiac Alliance

Colorado Springs, Colorado, 80907, United States

Location

Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center

Jacksonville, Florida, 32204, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital, Midtown

Emory, Georgia, 30308, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MAHI, Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78746, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84157, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital / Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Sunybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Severance Hospital

Seoul, 120-752, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Glowacki, Clinical Project Manager
• Organization: St. Jude Medical

NGlowacki@sjm.com

651-756-3432

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 26, 2019
• Results First Posted: May 23, 2014

Record last verified: 2019-02

Locations

CA (1); US (27); KR (2)