Phase
Condition
Dysrhythmia
Atrial Fibrillation
Heart Defect
Treatment
electrophysiology study and ablation with an Abbott Ablation Catheter
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must provide written informed consent prior to any clinicalinvestigation-related procedure.
Documented symptomatic persistent AF, which is defined as continuous AF sustainedbeyond 7 days and less than 1 year that is documented by a physician's note AND oneof the following:
a 24-hour Holter within 180 days prior to consent/enrollment, showingcontinuous AF OR
two electrocardiograms (from any form of rhythm monitoring) showing continuousAF: i. that are taken at least 7 days apart but less than 12 months apart. ii. Ifelectrocardiograms are more than 12 months apart, there must be one or more SRrecordings in between or within 12 months prior to consent/enrollment NOTE: The mostrecent ECG must be within 180 days of consent/enrollment. Documented evidence of theAF episode must either be continuous AF on a 12-lead ECG or include at least 30seconds of AF from another ECG device.
Subject must have failed, intolerance, or contraindication to a Class I-IV AADmedication.
Able and willing to comply with all pre-, post-, and follow-up testing andrequirements
Exclusion
Exclusion Criteria:
Previously diagnosed continuous AF >12 months (longstanding persistent AF)
Previous left atrial surgical or catheter ablation for atrial fibrillation or aprevious procedure that required an incision in the left atrium with resulting scar
Documented or known intracardiac thrombus on imaging
History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure
Patients with prosthetic valves
Diagnosed atrial myxoma
Acute illness or active systemic infection or sepsis
Patient is unlikely to survive the protocol follow up period of 36 months
Presence of other medical, social, or psychological conditions that, in theinvestigator's opinion, could limit the subject's ability to participate in theclinical investigation or to comply with follow-up requirements, or impact thescientific soundness of the clinical investigation results
Enrollment in an investigational study evaluating another device, biologic, or drugthat may interfere with this clinical investigation at the time of the initialprocedure or within 30 days prior to the initial procedure
Investigator deems at the time of screening for inclusion in the study that thepatient's treatment plan does not or likely will not include use of the studycatheter
Study Design
Study Description
Connect with a study center
Heart Center Research, LLC.
Huntsville, Alabama 35801
United StatesSite Not Available
Arkansas Cardiology
Little Rock, Arkansas 72205
United StatesSite Not Available
Eisenhower Medical Center
Rancho Mirage, California 92270
United StatesSite Not Available
Sequoia Hospital
Redwood City, California 94062
United StatesSite Not Available
Northside Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesSite Not Available
St. Patrick Hospital
Missoula, Montana 59802
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma 73135
United StatesSite Not Available
Doylestown Hospital
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Erlanger Medical Center
Chattanooga, Tennessee 37403
United StatesSite Not Available
Centennial Medical Center
Nashville, Tennessee 37203
United StatesSite Not Available
Methodist Hospital of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
St. Marks Hospital
Salt Lake City, Utah 84124
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
Chippenham Hospital
Richmond, Virginia 23225
United StatesSite Not Available
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