Informed Consent | Release of information consent
Item
able to sign informed consent and release of medical information forms
boolean
C0021430 (UMLS CUI [1])
C3166272 (UMLS CUI [2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Indication Mitral valve operation
Item
clinical indications for mitral valve surgery for the following:
boolean
C3146298 (UMLS CUI [1,1])
C0519382 (UMLS CUI [1,2])
Organic disease Mitral Valve
Item
1. organic mitral valve disease; or
boolean
C0683324 (UMLS CUI [1,1])
C0026264 (UMLS CUI [1,2])
Functional mitral regurgitation | Ischemia Excluded
Item
2. functional non-ischemic mitral regurgitation; or
boolean
C0340369 (UMLS CUI [1])
C0022116 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Ischaemic mitral regurgitation | Disease of mitral valve structural
Item
3. ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease
boolean
C4087284 (UMLS CUI [1])
C0026265 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
Patient need for Surgical Management Functional tricuspid regurgitation | Patient need for Surgical Management Patent Foramen Ovale | Coronary Artery Bypass Surgery | Aortic arch Interventional procedure | Aortic valve Interventional procedure | Sternotomy | Minimally Invasive Surgical Procedures
Item
note: may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. may also include concomitant cabg, aortic arch or aortic valve procedure. surgical intervention may be performed via sternotomy or minimally invasive procedure.
boolean
C0686904 (UMLS CUI [1,1])
C1515089 (UMLS CUI [1,2])
C0340392 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C1515089 (UMLS CUI [2,2])
C0016522 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C0003489 (UMLS CUI [4,1])
C0184661 (UMLS CUI [4,2])
C0003501 (UMLS CUI [5,1])
C0184661 (UMLS CUI [5,2])
C0185792 (UMLS CUI [6])
C0282624 (UMLS CUI [7])
Persistent atrial fibrillation Duration | Patient need for Pharmacological cardioversion | Patient need for Electric Countershock
Item
a) persistent af within 6 months prior to randomization, defined as non self-terminating af lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.
boolean
C2585653 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1963873 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0013778 (UMLS CUI [3,2])
Atrial Fibrillation Duration Medical History
Item
duration of af must be documented by medical history and
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Atrial Fibrillation Electrocardiography
Item
presence of af must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
boolean
C0004238 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Longstanding persistent atrial fibrillation Duration
Item
b) longstanding persistent af is defined as continuous af of greater than one year duration.
boolean
C3873617 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Atrial Fibrillation Duration Medical History
Item
duration of af must be documented by medical history and
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Atrial Fibrillation Electrocardiography
Item
presence of af must be documented by a direct electrocardiographic assessment upon arrival in the or.
boolean
C0004238 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Monitor heart rate and rhythm
Item
able to use heart rhythm monitor
boolean
C0513462 (UMLS CUI [1])
Atrial Fibrillation | Indication Absent Mitral valve operation | Paroxysmal atrial fibrillation | Thrombus of left atrium Transesophageal Echocardiography Intraoperative | Communicable Disease | Mental impairment | Study Protocol Comprehension Unable | Surgical Management Hypertrophic Cardiomyopathy | Catheter ablation for atrial fibrillation | Life Expectancy | Medical contraindication Anticoagulation Therapy | Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Hypothyroidism Uncontrolled | Hyperthyroidism Uncontrolled | Percent predicted FEV1 | Patient need for Home oxygen therapy | Pregnancy Pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling
Item
1. af without indication for mitral valve surgery 2. af is paroxysmal 3. evidence of left atrial thrombus by intra-operative tee 4. evidence of active infection 5. mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. surgical management of hypertrophic obstructive cardiomyopathy 7. previous catheter ablation for af 8. life expectancy of less than one year 9. absolute contraindications for anticoagulation therapy 10. enrollment in concomitant drug or device trials 11. uncontrolled hypo- or hyperthyroidism 12. fev1 < 30% of predicted value and/or need for home oxygen therapy 13. women who are pregnant as evidenced by positive pregnancy test 14. women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
boolean
C0004238 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0519382 (UMLS CUI [2,3])
C0235480 (UMLS CUI [3])
C3532827 (UMLS CUI [4,1])
C0206054 (UMLS CUI [4,2])
C0456904 (UMLS CUI [4,3])
C0009450 (UMLS CUI [5])
C0683322 (UMLS CUI [6])
C2348563 (UMLS CUI [7,1])
C0162340 (UMLS CUI [7,2])
C1299582 (UMLS CUI [7,3])
C1515089 (UMLS CUI [8,1])
C0007194 (UMLS CUI [8,2])
C2702800 (UMLS CUI [9])
C0023671 (UMLS CUI [10])
C1301624 (UMLS CUI [11,1])
C0003281 (UMLS CUI [11,2])
C2348568 (UMLS CUI [12])
C0013230 (UMLS CUI [13])
C2346570 (UMLS CUI [14])
C0020676 (UMLS CUI [15,1])
C0205318 (UMLS CUI [15,2])
C0020550 (UMLS CUI [16,1])
C0205318 (UMLS CUI [16,2])
C0730561 (UMLS CUI [17])
C0686904 (UMLS CUI [18,1])
C1960973 (UMLS CUI [18,2])
C0032961 (UMLS CUI [19,1])
C0240802 (UMLS CUI [19,2])
C3831118 (UMLS CUI [20,1])
C0700589 (UMLS CUI [20,2])
C0558080 (UMLS CUI [20,3])