Phase
Condition
Chest Pain
Heart Defect
Dysrhythmia
Treatment
N/AClinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients between the ages of 21 and 85 years
Diagnosed with symptomatic persistent AF Documentation of history of AF for at least 6months AF not spontaneously converting to sinus rhythm, persisting for ≥7 days Sinusrhythm after cardioversion is NOT exclusion, provided that≥2 episodes of persistent AFoccurred in the previous 6 months
Resistant or intolerant to at least one class I, II, or III anti arrhythmic drugs (AAD)
Patients deemed candidates for radio frequency(RF) ablation of AF
Able and willing to comply with pre-, post-, and follow-up requirements.
Exclusion
Exclusion Criteria:
Patients with previous PVAI procedure or left heart ablation procedure.
Left atrial thrombus.
LA diameter greater than 65 mm on long axis parasternal view, or left atrial volumemore than 200 cc by MRI or CT.
Left ventricular ejection fraction < 30%.
Cardiac surgery within the previous 180 days.
Expecting cardiac transplantation or other cardiac surgery within 180 days.
Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within theprevious 90 days.
Documented history of a thrombi-embolic event within the previous 90 days.
Diagnosed atrial myxoma.
Significant restrictive, constrictive, or chronic obstructive pulmonary disease withchronic symptoms.
Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment
Women who are pregnant.
Acute illness or active infection at time of index procedure documented by eitherpain, fever, drainage, positive culture and/or leukocytosis (WBC > 11. 000 mm3) forwhich antibiotics have been or will be prescribed.
Creatinine> 2. 5 mg/dl (or > 221 μmol/L, except for patients in dialysis).
Unstable angina.
Myocardial infarction within the previous 60 days.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation.
Contraindication to computed tomography or MRI procedures.
Life expectancy less than 1 year.
Uncontrolled heart failure.
Presence of an intramural thrombus, tumor, or other abnormality that precludescatheter introduction or positioning.
Presence of a condition that precludes vascular access.
Institute for Natural Resources (INR) greater than 3. 5 within 24 hours of procedure.
Cannot be removed from antiarrhythmic drugs for reasons other than AF.
Unwilling or unable to provide informed consent.
Current reported alcoholism.
Study Design
Study Description
Connect with a study center
Arizona Heart Rhythm Center
Phoenix, Arizona 85013
United StatesSite Not Available
USC Los Angeles - Keck Hopsital
Los Angeles, California 90033
United StatesSite Not Available
San Diego Cardiac Center
San Diego, California 92123
United StatesSite Not Available
University of Colorado School of Medicince, Denver
Denver, Colorado 80045
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30308
United StatesSite Not Available
KUMC Research Institute
Kansas City, Kansas 66160
United StatesSite Not Available
St. Luke's Hospital Duluth
Duluth, Minnesota 55802
United StatesSite Not Available
Texas Cardiac Arrythmia Research Foundation
Austin, Texas 78705
United StatesSite Not Available
BCM/CHI St. Luke's Hospital
Houston, Texas 77030
United StatesSite Not Available
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
Houston VAMC
Houston, Texas 77030
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23292
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.