ID

37449

Description

Radiofrequency Ablation of Drivers of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00674401

Link

https://clinicaltrials.gov/show/NCT00674401

Keywords

Versions (1)
  1. 7/28/19 7/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00674401

English

Eligibility Atrial Fibrillation NCT00674401

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age 18 or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with paroxysmal af symptomatic and refractory to at least one antiarrhythmic medication.
Description

Paroxysmal atrial fibrillation Symptomatic | Unresponsive to Anti-Arrhythmia Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0003195
UMLS CUI [2,3]
C1265611
in patients with paroxysmal af, at least one episode of af must have been documented by ecg or holter within 12 months of randomization in the trial.
Description

Paroxysmal atrial fibrillation | Episode of Atrial Fibrillation Quantity ECG | Episode of Atrial Fibrillation Quantity Holter Electrocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C0004238
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0013798
UMLS CUI [3,1]
C0332189
UMLS CUI [3,2]
C0004238
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0013801
patients with persistent af defined as a sustained episode that had been present for more than seven days without intervening spontaneous episodes of sinus rhythm and that recurred within seven days after cardioversion.
Description

Persistent atrial fibrillation | Episode of Atrial Fibrillation Duration | Episode of Sinus rhythm Absent | Recurrent episode Post Cardioversion

Data type

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]
C0232201
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0443287
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0013778
patients with persistent af must be on continuous anticoagulation with warfarin (inr 2-3) for> 4 weeks prior to ablation. in patients with paroxysmal af no continuous anticoagulation therapy with warfarin for > 4 weeks prior to ablation will be needed provided a transesophageal echocardiogram performed prior to ablation exclude the presence of thrombi or other abnormalities that discourage performing the procedure.
Description

Persistent atrial fibrillation | Anticoagulation Therapy | Warfarin | INR | Status pre- Ablation | Paroxysmal atrial fibrillation | Echocardiography, Transesophageal | Thrombi Excluded | Abnormality Excluded

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C0003281
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0525032
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C0547070
UMLS CUI [6]
C0235480
UMLS CUI [7]
C0206054
UMLS CUI [8,1]
C0087086
UMLS CUI [8,2]
C0332196
UMLS CUI [9,1]
C1704258
UMLS CUI [9,2]
C0332196
patients must be able and willing to provide written informed consent to participate in the clinical trial.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with af secondary to reversible causes.
Description

Atrial Fibrillation Secondary to Cause Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
patients with inadequate anticoagulation levels as defined in the inclusion criteria.
Description

Anticoagulation drug level Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C1168142
UMLS CUI [1,2]
C0205412
patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on tee prior to the procedure.
Description

Thrombus of left atrium | Neoplasm | Abnormality Excludes Catheterization Transesophageal Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C3532827
UMLS CUI [2]
C0027651
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0007430
UMLS CUI [3,4]
C0206054
patients with contraindications to systemic anticoagulation with heparin or coumadin.
Description

Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0699129
patients who have previously undergone atrial fibrillation ablation, either by surgery or by percutaneous catheter.
Description

Atrial Fibrillation Ablation | Operative Surgical Procedures | Catheter Ablation, Percutaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0547070
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0162560
patients with left atrial size > 55 mm.
Description

Left atrium Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
patients who are or may potentially be pregnant.
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
patients with hyperthyroidism or hypothyroidism.
Description

Hyperthyroidism | Hypothyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0020676
current enrollment in another investigational drug or device study.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
pacemaker or implantable cardioverter defibrillator.
Description

Artificial cardiac pacemaker | Implantable defibrillator

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
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Similar models

Eligibility Atrial Fibrillation NCT00674401

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients age 18 or older.
boolean
C0001779 (UMLS CUI [1])
Paroxysmal atrial fibrillation Symptomatic | Unresponsive to Anti-Arrhythmia Agents Quantity
Item
patients with paroxysmal af symptomatic and refractory to at least one antiarrhythmic medication.
boolean
C0235480 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0003195 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Paroxysmal atrial fibrillation | Episode of Atrial Fibrillation Quantity ECG | Episode of Atrial Fibrillation Quantity Holter Electrocardiography
Item
in patients with paroxysmal af, at least one episode of af must have been documented by ecg or holter within 12 months of randomization in the trial.
boolean
C0235480 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0013798 (UMLS CUI [2,4])
C0332189 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0013801 (UMLS CUI [3,4])
Persistent atrial fibrillation | Episode of Atrial Fibrillation Duration | Episode of Sinus rhythm Absent | Recurrent episode Post Cardioversion
Item
patients with persistent af defined as a sustained episode that had been present for more than seven days without intervening spontaneous episodes of sinus rhythm and that recurred within seven days after cardioversion.
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])
C0232201 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0443287 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0013778 (UMLS CUI [4,3])
Persistent atrial fibrillation | Anticoagulation Therapy | Warfarin | INR | Status pre- Ablation | Paroxysmal atrial fibrillation | Echocardiography, Transesophageal | Thrombi Excluded | Abnormality Excluded
Item
patients with persistent af must be on continuous anticoagulation with warfarin (inr 2-3) for> 4 weeks prior to ablation. in patients with paroxysmal af no continuous anticoagulation therapy with warfarin for > 4 weeks prior to ablation will be needed provided a transesophageal echocardiogram performed prior to ablation exclude the presence of thrombi or other abnormalities that discourage performing the procedure.
boolean
C2585653 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
C0332152 (UMLS CUI [5,1])
C0547070 (UMLS CUI [5,2])
C0235480 (UMLS CUI [6])
C0206054 (UMLS CUI [7])
C0087086 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C1704258 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
Informed Consent
Item
patients must be able and willing to provide written informed consent to participate in the clinical trial.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Secondary to Cause Reversible
Item
patients with af secondary to reversible causes.
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Anticoagulation drug level Inadequate
Item
patients with inadequate anticoagulation levels as defined in the inclusion criteria.
boolean
C1168142 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Thrombus of left atrium | Neoplasm | Abnormality Excludes Catheterization Transesophageal Echocardiography
Item
patients with left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on tee prior to the procedure.
boolean
C3532827 (UMLS CUI [1])
C0027651 (UMLS CUI [2])
C1704258 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0007430 (UMLS CUI [3,3])
C0206054 (UMLS CUI [3,4])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin
Item
patients with contraindications to systemic anticoagulation with heparin or coumadin.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
Atrial Fibrillation Ablation | Operative Surgical Procedures | Catheter Ablation, Percutaneous
Item
patients who have previously undergone atrial fibrillation ablation, either by surgery or by percutaneous catheter.
boolean
C0004238 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0162560 (UMLS CUI [3])
Left atrium Size
Item
patients with left atrial size > 55 mm.
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pregnancy | Possible pregnancy
Item
patients who are or may potentially be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Hyperthyroidism | Hypothyroidism
Item
patients with hyperthyroidism or hypothyroidism.
boolean
C0020550 (UMLS CUI [1])
C0020676 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
current enrollment in another investigational drug or device study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Artificial cardiac pacemaker | Implantable defibrillator
Item
pacemaker or implantable cardioverter defibrillator.
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
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