ID

39590

Beschreibung

Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01420393

Link

https://clinicaltrials.gov/show/NCT01420393

Stichworte

Versionen (1)
  1. 01.02.20 01.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01420393

Englisch

Eligibility Heart Failure NCT01420393

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with one of the following af categories and at least one ecg documentation of af
Beschreibung

Atrial Fibrillation Categories Quantity | Atrial Fibrillation by ECG Finding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0683312
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0344434
high burden paroxysmal defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)
Beschreibung

Paroxysmal atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Absent Electric Countershock

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0013778
persistent af (1) defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours, and at least one af episode less than 7 days but requires cardioversion. no af episodes are > 7 days
Beschreibung

Persistent atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Electric Countershock

Datentyp

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0013778
persistent af (2) as defined by at least one episode of af > 7 days but not > 1 year
Beschreibung

Persistent atrial fibrillation | Episode of Atrial Fibrillation Duration | Episode Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C1265611
long term persistent af defined as an af episode, at least one year in length and no episodes > 3 years
Beschreibung

Persistent atrial fibrillation Long-term | Episode of Atrial Fibrillation Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C0449238
2. optimal therapy for heart failure of at least 6 weeks (according to 2009 accf/aha class 1 recommendations).
Beschreibung

Therapy Optimal Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
3. hf with nyha class ii or iii symptoms with either impaired lv function (lvef ≤ 45%) as determined by ef assessment within the previous 12 months or preserved lv function (lvef > 45%) determined by by ef assessment within the previous 12 months
Beschreibung

Heart failure Symptoms New York Heart Association Classification | Ventricular Dysfunction, Left | Left ventricular ejection fraction | Left Ventricular Function Preserved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
UMLS CUI [2]
C0242698
UMLS CUI [3]
C0428772
UMLS CUI [4,1]
C0080310
UMLS CUI [4,2]
C0033085
4. nt-pro bnp measures:
Beschreibung

N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C3272900
a) patient has been hospitalized for heart failure* in the past 9 months, has been discharged and:
Beschreibung

Hospitalization Due to Heart Failure | Patient Discharge

Datentyp

boolean

Alias
UMLS CUI [1]
C3898876
UMLS CUI [2]
C0030685
i- is presently in normal sinus rhythm and nt-pro bnp is ≥ 400 pg/ml
Beschreibung

Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232202
UMLS CUI [2]
C3272900
ii- is presently in atrial fibrillation and nt-pro bnp is ≥ 600 pg/ml
Beschreibung

Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C3272900
b) patient has had no hospitalization for heart failure in the past 9 months and:
Beschreibung

Hospitalization Due to Heart Failure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C0332197
i- has had paroxysmal atrial fibrillation, is presently in normal sinus rhythm and nt-probnp is ≥ 600 pg/ml
Beschreibung

Paroxysmal atrial fibrillation | Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C0232202
UMLS CUI [3]
C3272900
ii- is presently in atrial fibrillation and nt-probnp is ≥ 900 pg/ml
Beschreibung

Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C3272900
*heart failure admission is defined as admission to hospital > 24 hours and received treatment for heart failure
Beschreibung

Hospital admission Heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0018801
5. suitable candidate for catheter ablation or rate control therapy for the treatment of af
Beschreibung

Patient Appropriate Catheter ablation for atrial fibrillation | Rate control Therapy Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2702800
UMLS CUI [2,1]
C0489879
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0004238
6. age ≥18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have an la dimension > 55 mm as determined by an echocardiography within the previous year
Beschreibung

Left atrium Dimension Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0439534
UMLS CUI [1,3]
C0013516
2. had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
Beschreibung

Acute Coronary Syndrome | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0010055
3. have rheumatic heart disease, severe aortic or mitral valvular heart disease using the aha/acc guidelines
Beschreibung

Rheumatic Heart Disease | Aortic valve disorder Severe | Disease of mitral valve Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0035439
UMLS CUI [2,1]
C1260873
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0026265
UMLS CUI [3,2]
C0205082
4. have congenital heart disease including previous asd repair, persistent left superior vena cava
Beschreibung

Congenital heart disease | Atrioseptoplasty Previous | Persistent left superior vena cava

Datentyp

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C0189965
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C0265931
5. had prior surgical or percutaneous af ablation procedure or atrioventricular nodal (avn) ablation
Beschreibung

Catheter ablation for atrial fibrillation Previous | Percutaneous Catheter Ablation Atrial Fibrillation | Ablation of atrioventricular node

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0162560
UMLS CUI [2,2]
C0004238
UMLS CUI [3]
C1998174
6. have a medical condition likely to limit survival to < 1 year
Beschreibung

Medical condition Reduced life expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1858274
7. have new york heart association (nyha) class iv heart failure symptoms
Beschreibung

Heart failure Symptoms New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
8. have contraindication to systematic anticoagulation
Beschreibung

Medical contraindication Anticoagulation Therapy systematic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0220922
9. have renal failure requiring dialysis
Beschreibung

Kidney Failure Requirement Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
10. af due to reversible cause e.g. hyperthyroid state
Beschreibung

Atrial Fibrillation Due to Cause Reversible | Hyperthyroidism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
UMLS CUI [2]
C0020550
11. are pregnant
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
12. are included in other clinical trials that will affect the objectives of this study
Beschreibung

Study Subject Participation Status Affecting Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2732579
13. have a history of non-compliance to medical therapy
Beschreibung

Treatment Compliance Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332268
14. are unable or unwilling to provide informed consent
Beschreibung

Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Ähnliche Modelle

Eligibility Heart Failure NCT01420393

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation Categories Quantity | Atrial Fibrillation by ECG Finding
Item
1. patients with one of the following af categories and at least one ecg documentation of af
boolean
C0004238 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0344434 (UMLS CUI [2])
Paroxysmal atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Absent Electric Countershock
Item
high burden paroxysmal defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)
boolean
C0235480 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0013778 (UMLS CUI [4,3])
Persistent atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Electric Countershock
Item
persistent af (1) defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours, and at least one af episode less than 7 days but requires cardioversion. no af episodes are > 7 days
boolean
C2585653 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])
Persistent atrial fibrillation | Episode of Atrial Fibrillation Duration | Episode Quantity
Item
persistent af (2) as defined by at least one episode of af > 7 days but not > 1 year
boolean
C2585653 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Persistent atrial fibrillation Long-term | Episode of Atrial Fibrillation Duration
Item
long term persistent af defined as an af episode, at least one year in length and no episodes > 3 years
boolean
C2585653 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Therapy Optimal Heart failure
Item
2. optimal therapy for heart failure of at least 6 weeks (according to 2009 accf/aha class 1 recommendations).
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Heart failure Symptoms New York Heart Association Classification | Ventricular Dysfunction, Left | Left ventricular ejection fraction | Left Ventricular Function Preserved
Item
3. hf with nyha class ii or iii symptoms with either impaired lv function (lvef ≤ 45%) as determined by ef assessment within the previous 12 months or preserved lv function (lvef > 45%) determined by by ef assessment within the previous 12 months
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0242698 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C0080310 (UMLS CUI [4,1])
C0033085 (UMLS CUI [4,2])
N-Terminal ProB-type Natriuretic Peptide Measurement
Item
4. nt-pro bnp measures:
boolean
C3272900 (UMLS CUI [1])
Hospitalization Due to Heart Failure | Patient Discharge
Item
a) patient has been hospitalized for heart failure* in the past 9 months, has been discharged and:
boolean
C3898876 (UMLS CUI [1])
C0030685 (UMLS CUI [2])
Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
i- is presently in normal sinus rhythm and nt-pro bnp is ≥ 400 pg/ml
boolean
C0232202 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
ii- is presently in atrial fibrillation and nt-pro bnp is ≥ 600 pg/ml
boolean
C0004238 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Hospitalization Due to Heart Failure Absent
Item
b) patient has had no hospitalization for heart failure in the past 9 months and:
boolean
C3898876 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Paroxysmal atrial fibrillation | Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
i- has had paroxysmal atrial fibrillation, is presently in normal sinus rhythm and nt-probnp is ≥ 600 pg/ml
boolean
C0235480 (UMLS CUI [1])
C0232202 (UMLS CUI [2])
C3272900 (UMLS CUI [3])
Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement
Item
ii- is presently in atrial fibrillation and nt-probnp is ≥ 900 pg/ml
boolean
C0004238 (UMLS CUI [1])
C3272900 (UMLS CUI [2])
Hospital admission Heart failure
Item
*heart failure admission is defined as admission to hospital > 24 hours and received treatment for heart failure
boolean
C0184666 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
Patient Appropriate Catheter ablation for atrial fibrillation | Rate control Therapy Atrial Fibrillation
Item
5. suitable candidate for catheter ablation or rate control therapy for the treatment of af
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2702800 (UMLS CUI [1,3])
C0489879 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Age
Item
6. age ≥18
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Left atrium Dimension Echocardiography
Item
1. have an la dimension > 55 mm as determined by an echocardiography within the previous year
boolean
C0225860 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Acute Coronary Syndrome | Coronary Artery Bypass Surgery
Item
2. had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
boolean
C0948089 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Rheumatic Heart Disease | Aortic valve disorder Severe | Disease of mitral valve Severe
Item
3. have rheumatic heart disease, severe aortic or mitral valvular heart disease using the aha/acc guidelines
boolean
C0035439 (UMLS CUI [1])
C1260873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0026265 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Congenital heart disease | Atrioseptoplasty Previous | Persistent left superior vena cava
Item
4. have congenital heart disease including previous asd repair, persistent left superior vena cava
boolean
C0152021 (UMLS CUI [1])
C0189965 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0265931 (UMLS CUI [3])
Catheter ablation for atrial fibrillation Previous | Percutaneous Catheter Ablation Atrial Fibrillation | Ablation of atrioventricular node
Item
5. had prior surgical or percutaneous af ablation procedure or atrioventricular nodal (avn) ablation
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0162560 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1998174 (UMLS CUI [3])
Medical condition Reduced life expectancy
Item
6. have a medical condition likely to limit survival to < 1 year
boolean
C3843040 (UMLS CUI [1,1])
C1858274 (UMLS CUI [1,2])
Heart failure Symptoms New York Heart Association Classification
Item
7. have new york heart association (nyha) class iv heart failure symptoms
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Medical contraindication Anticoagulation Therapy systematic
Item
8. have contraindication to systematic anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0220922 (UMLS CUI [1,3])
Kidney Failure Requirement Dialysis
Item
9. have renal failure requiring dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Atrial Fibrillation Due to Cause Reversible | Hyperthyroidism
Item
10. af due to reversible cause e.g. hyperthyroid state
boolean
C0004238 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
C0020550 (UMLS CUI [2])
Pregnancy
Item
11. are pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status Affecting Completion of clinical trial
Item
12. are included in other clinical trials that will affect the objectives of this study
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Treatment Compliance Lacking
Item
13. have a history of non-compliance to medical therapy
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
14. are unable or unwilling to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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