ID

16265

Description

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

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00259623

English

Eligibility Atrial Fibrillation NCT00259623

1 forms  
Inclusion Criteria
Description

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)
Description

Chronic atrial fibrillation

Data type

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.
Description

Chronic atrial fibrillation definition

Data type

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)
Description

Indication for surgery

Data type

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
Description

Informed consent

Data type

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.
Description

Informed consent

Data type

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.
Description

Modified informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Paroxystic atrial fibrillation

Data type

boolean

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

Cardioversion or pharmacology

Data type

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
Description

contra-indication to surgery

Data type

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).
Description

contra-indication to arrhythmia treatments

Data type

boolean

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

severe decompensated heart failure.

Data type

boolean

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

ventricular arrhythmia

Data type

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.
Description

contra indication to epicardic ablation procedure

Data type

boolean

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

Ventricular ejection fraction

Data type

boolean

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

Impossibility to follow the pre-inclusion phases

Data type

boolean

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

disabled mental status

Data type

boolean

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

Study participation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT00259623

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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