Phase
Condition
Cardiac Disease
Atrial Fibrillation
Arrhythmia
Treatment
Radiofrequency Ablation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with symptomatic PAF who have had three (3) AF episodes in the six (6)months prior to enrollment, one of which must be documented. Documentation mayinclude electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM),or telemetry strip.
Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents suchas beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrentsymptomatic PAF, or intolerable side effects due to AAD.
Signed Patient Informed Consent Form.
Age 18 years or older.
Able and willing to comply with all pre-, post- and follow-up testing andrequirements.
Exclusion
Exclusion Criteria:
Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, orreversible or non- cardiac cause.
Previous ablation for atrial fibrillation.
Patients on amiodarone therapy at any time during the previous six (6) months.
AF episodes that last longer than 30 days and are terminated via cardioversion.
Any valvular cardiac surgical procedure.
CABG procedure within the last 180 days (six months).
Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
Documented left atrial thrombus on imaging (e.g. TEE).
History of a documented thromboembolic event within the past one (1) year.
Diagnosed atrial myxoma.
Presence of implanted ICD.
Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces chronic symptoms.
Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study.
Women who are pregnant (by history of menstrual period or pregnancy test if thehistory is considered unreliable).
Acute illness or active systemic infection or sepsis.
Unstable angina.
Myocardial infarction within the previous 60 days (two months).
LVEF < 40%.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e. heparin or warfarin).
Contraindication to CT/MRA procedure.
Life expectancy less than 360 days (12 months).
Enrollment in an investigational study evaluating another device or drug.
Uncontrolled heart failure or NYHA class III or IV heart failure.
Presence of intramural thrombus, tumor or other abnormality that precludes catheterintroduction or manipulation.
Presence of a condition that precludes vascular access.
Study Design
Connect with a study center
Montreal Heart Institute
Montreal, Quebec H1T 1CB
CanadaSite Not Available
University of Alabama, Birmingham Medical Center
Birmingham, Alabama 35294
United StatesSite Not Available
Arizona Arrhythmia Consultants
Scottsdale, Arizona 85251
United StatesSite Not Available
Marin General Hospital
Greenbrae, California 94904
United StatesSite Not Available
Florida Hospital Orlando
Orlando, Florida 32803
United StatesSite Not Available
Loyola University Medical Center Chicago
Maywood, Illinois 60153
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
St. Luke's Roosevelt Hospital
New York, New York 10025
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio State University Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
University of Oklahoma
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
The Pennsylvania State University and Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Texas Cardiac Associates
Rowlett, Texas 75088
United StatesSite Not Available
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