ID

16265

Descrizione

Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months; ODM derived from: https://clinicaltrials.gov/show/NCT00259623

collegamento

https://clinicaltrials.gov/show/NCT00259623

Keywords

versioni (1)
  1. 08/07/16 08/07/16 -
Caricato su

8 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00259623

Inglese

Eligibility Atrial Fibrillation NCT00259623

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Descrizione

Chronic atrial fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0694539
UMLS CUI [2]
C2921036
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.
Descrizione

Chronic atrial fibrillation definition

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0694539
UMLS CUI [1,2]
C1704788
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)
Descrizione

Indication for surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2315323
UMLS CUI [2]
C1275491
patients with a vital prognosis not compromised by comorbidity in the next 2 years and with a mental state enabling to give informed consent
Descrizione

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278060
UMLS CUI [2]
C0021430
patients agreeing to take part in the study and having signed the informed consent form.
Descrizione

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
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.
Descrizione

Modified informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
paroxystic atrial fibrillation or atrial fibrillation for less than 1 month
Descrizione

Paroxystic atrial fibrillation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0235480
atrial fibrillation never treated by cardioversion or pharmacology before surgery.
Descrizione

Cardioversion or pharmacology

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0199550
UMLS CUI [2]
C2924557
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
Descrizione

contra-indication to surgery

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0852649
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).
Descrizione

contra-indication to arrhythmia treatments

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3845816
severe decompensated heart failure.
Descrizione

severe decompensated heart failure.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0581377
UMLS CUI [1,2]
C0205082
uncontrolled, repetitive, severe documented ventricular arrhythmia (ventricular tachycardia, ventricular fibrillation episodes)
Descrizione

ventricular arrhythmia

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0085612
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.
Descrizione

contra indication to epicardic ablation procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0420588
UMLS CUI [1,2]
C2825182
ventricular "ejection fraction " < 40%
Descrizione

Ventricular ejection fraction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042508
impossibility to follow the pre-inclusion phases i.e. emergency surgery for mitral break or evolutive endocarditis.
Descrizione

Impossibility to follow the pre-inclusion phases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2216322
UMLS CUI [2]
C0014118
patients with disabled mental status
Descrizione

disabled mental status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0278061
patient participating in another clinical study
Descrizione

Study participation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT00259623

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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])
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