Informationen:
Fehler:
ID
16265
Beschreibung
Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months; ODM derived from: https://clinicaltrials.gov/show/NCT00259623
Link
https://clinicaltrials.gov/show/NCT00259623
Stichworte
Versionen (1)
- 08.07.16 08.07.16 -
Hochgeladen am
8. Juli 2016
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00259623
Eligibility Atrial Fibrillation NCT00259623
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Atrial Fibrillation NCT00259623
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Chronic atrial fibrillation
Item
adult patients with no age limit, presenting a chronic atrial fibrillation and planned to undergo a surgical intervention on mitral valve (valve replacement or plasty) associated or not with myocardial revascularization or replacement/plasty of another valve (aortic, tricuspid)
boolean
C0694539 (UMLS CUI [1])
C2921036 (UMLS CUI [2])
C2921036 (UMLS CUI [2])
Chronic atrial fibrillation definition
Item
the chronic atrial fibrillation is defined as a continuous atrial fibrillation more than 1 month before the surgery despite all anti-arrhythmia treatments including cardioversion ; the atrial fibrillation can be associated to another rhythm trouble except the severe ventricular rhythm troubles.
boolean
C0694539 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,2])
Indication for surgery
Item
the indication for surgery is performed using the clinical evaluation : nyha >2 and the usual echocardiography criteria (mitral regurgitation > grade 3, mitral gradient >10 mm hg or valve surface < 1,5 cm2)
boolean
C2315323 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
Informed consent
Item
patients with a vital prognosis not compromised by comorbidity in the next 2 years and with a mental state enabling to give informed consent
boolean
C0278060 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
Informed consent
Item
patients agreeing to take part in the study and having signed the informed consent form.
boolean
C0021430 (UMLS CUI [1])
Modified informed consent
Item
for the part of the study pursued in open independent to the actual protocol, patients having signed the modified informed consent with approval of the new study procedure not yet published.
boolean
C0021430 (UMLS CUI [1])
Paroxystic atrial fibrillation
Item
paroxystic atrial fibrillation or atrial fibrillation for less than 1 month
boolean
C0235480 (UMLS CUI [1])
Cardioversion or pharmacology
Item
atrial fibrillation never treated by cardioversion or pharmacology before surgery.
boolean
C0199550 (UMLS CUI [1])
C2924557 (UMLS CUI [2])
C2924557 (UMLS CUI [2])
contra-indication to surgery
Item
contra-indication to surgery, i.e. severe respiratory failures, multivisceral deficiencies (renal, cardiac or hepatic), rapidly evolutive or metastatic cancers, malignant hemopathies not stabilized by chemotherapy
boolean
C0852649 (UMLS CUI [1])
contra-indication to arrhythmia treatments
Item
contra-indication to the following arrhythmia treatments: class iii (amiodarone) associated to contra-indication to class ii (beta blockers) or to class ic (flecainide, propafenone, cibenzoline).
boolean
C3845816 (UMLS CUI [1])
severe decompensated heart failure.
Item
severe decompensated heart failure.
boolean
C0581377 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
ventricular arrhythmia
Item
uncontrolled, repetitive, severe documented ventricular arrhythmia (ventricular tachycardia, ventricular fibrillation episodes)
boolean
C0085612 (UMLS CUI [1])
contra indication to epicardic ablation procedure
Item
contra indication to epicardic ablation procedure (pericardic adhesions, intra-atrial thrombus) in these cases the ablation could be only an endocardic ablation but it does not necessarily exclude the patient.
boolean
C0420588 (UMLS CUI [1,1])
C2825182 (UMLS CUI [1,2])
C2825182 (UMLS CUI [1,2])
Ventricular ejection fraction
Item
ventricular "ejection fraction " < 40%
boolean
C0042508 (UMLS CUI [1])
Impossibility to follow the pre-inclusion phases
Item
impossibility to follow the pre-inclusion phases i.e. emergency surgery for mitral break or evolutive endocarditis.
boolean
C2216322 (UMLS CUI [1])
C0014118 (UMLS CUI [2])
C0014118 (UMLS CUI [2])
disabled mental status
Item
patients with disabled mental status
boolean
C0278061 (UMLS CUI [1])
Study participation
Item
patient participating in another clinical study
boolean
C2348568 (UMLS CUI [1])