ID

37521

Description

DAPPAR AF Dabigatran for Peri Procedural Anticoagulation During Radiofrequency Ablation of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01468155

Lien

https://clinicaltrials.gov/show/NCT01468155

Mots-clés

Versions (1)
  1. 04/08/2019 04/08/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 août 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01468155

Anglais

Eligibility Atrial Fibrillation NCT01468155

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients age 18 or greater.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patients undergoing first-time catheter ablation for af.
Description

Catheter ablation for atrial fibrillation Firstly

Type de données

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1279901
patients with paroxysmal or persistent af. paroxysmal af will be defined as self-terminating episodes less than 7 days duration. persistent af will be defined as episodes that last longer than 7 days duration or episodes requiring termination by electrical or chemical cardioversion.
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Paroxysmal atrial fibrillation Episode Duration | Persistent atrial fibrillation Episode Duration | Persistent atrial fibrillation Episode Requirement Electric Countershock | Persistent atrial fibrillation Episode Requirement Chemical cardioversion

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3,1]
C0235480
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C0449238
UMLS CUI [4,1]
C2585653
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C0449238
UMLS CUI [5,1]
C2585653
UMLS CUI [5,2]
C0332189
UMLS CUI [5,3]
C1514873
UMLS CUI [5,4]
C0013778
UMLS CUI [6,1]
C2585653
UMLS CUI [6,2]
C0332189
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C2585199
patients with symptomatic af that is refractory to at least one antiarrhythmic medication. "symptomatic" patients are those who have been aware of their af anytime within the last 5 years prior to enrollment. symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
Description

ATRIAL FIBRILLATION SYMPTOMATIC Unresponsive to Anti-Arrhythmia Agents Quantity | Symptoms | Palpitations | Dyspnea | Chest Pain | Fatigue | Ventricular Dysfunction, Left | Combination Symptoms

Type de données

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0003195
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C1457887
UMLS CUI [3]
C0030252
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0008031
UMLS CUI [6]
C0015672
UMLS CUI [7]
C0242698
UMLS CUI [8,1]
C0205195
UMLS CUI [8,2]
C1457887
at least one episode of af must have been documented by ecg, holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of entry in the trial.
Description

Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Fibrillation Episode Quantity Holter Electrocardiography | Atrial Fibrillation Episode Quantity Loop recorder | Atrial Fibrillation Episode Quantity Telemetry | Other Coding

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1623258
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0013801
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C3838353
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0039451
UMLS CUI [5]
C3846158
patients must be able and willing to provide written informed consent to participate in the clinical trial.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with af felt to be secondary to an obvious reversible cause (e.g. thyroid disease, post-surgical).
Description

Atrial Fibrillation Secondary to Cause Reversible | Thyroid Disease | Status post Operative Surgical Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
UMLS CUI [2]
C0040128
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
Description

Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Direct Thrombin Inhibitor

Type de données

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]
C3536847
patients with severe renal impairment (creatinine clearance of <30 ml/min)
Description

Renal Insufficiency Severe | Creatinine clearance measurement

Type de données

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0373595
patients with left atrial size >/= 60 mm (2d echocardiography, parasternal long axis view).
Description

Left atrium Size 2D Echocardiography Parasternal long axis view

Type de données

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0013524
UMLS CUI [1,4]
C1302222
patients who are or may potentially be pregnant or who are not on an effective method of birth control or who are planning to get pregnant during the study.
Description

Pregnancy | Possible pregnancy | Contraceptive methods Absent | Pregnancy, Planned

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0032992
patients with mechanical heart valves.
Description

HEART-VALVE, MECHANICAL

Type de données

boolean

Alias
UMLS CUI [1]
C0493527
patients who are undergoing repeat catheter ablation of af.
Description

Catheter ablation for atrial fibrillation Repeated

Type de données

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205341
patients with hemorrhagic manifestations, bleeding diathesis, or patients with impairment of hemostasis.
Description

Manifestation Hemorrhagic | Bleeding tendency | Hemostasis Impairment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205319
UMLS CUI [1,2]
C0333275
UMLS CUI [2]
C1458140
UMLS CUI [3,1]
C0019116
UMLS CUI [3,2]
C0221099
lesions at risk of clinically significant bleeding - such as extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding.
Description

Lesion Bleeding risk | Cerebral Infarction Extensive | Peptic Ulcer with Hemorrhage Recent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3251812
UMLS CUI [2,1]
C0007785
UMLS CUI [2,2]
C0205231
UMLS CUI [3,1]
C0030920
UMLS CUI [3,2]
C0332287
UMLS CUI [3,3]
C0019080
UMLS CUI [3,4]
C0332185
concomitant treatment with strong p-glycoprotein inhibitors, i.e. ketoconazole.
Description

P-Glycoprotein Inhibitors Strong | Ketoconazole

Type de données

boolean

Alias
UMLS CUI [1,1]
C3500483
UMLS CUI [1,2]
C0442821
UMLS CUI [2]
C0022625
known hypersensitivity to dabigatran or dabigatran etexilate.
Description

Hypersensitivity Dabigatran | Hypersensitivity Dabigatran etexilate

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2348066
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1571583
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Similar models

Eligibility Atrial Fibrillation NCT01468155

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients age 18 or greater.
boolean
C0001779 (UMLS CUI [1])
Catheter ablation for atrial fibrillation Firstly
Item
patients undergoing first-time catheter ablation for af.
boolean
C2702800 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Paroxysmal atrial fibrillation Episode Duration | Persistent atrial fibrillation Episode Duration | Persistent atrial fibrillation Episode Requirement Electric Countershock | Persistent atrial fibrillation Episode Requirement Chemical cardioversion
Item
patients with paroxysmal or persistent af. paroxysmal af will be defined as self-terminating episodes less than 7 days duration. persistent af will be defined as episodes that last longer than 7 days duration or episodes requiring termination by electrical or chemical cardioversion.
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0235480 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C2585653 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C2585653 (UMLS CUI [5,1])
C0332189 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
C0013778 (UMLS CUI [5,4])
C2585653 (UMLS CUI [6,1])
C0332189 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C2585199 (UMLS CUI [6,4])
ATRIAL FIBRILLATION SYMPTOMATIC Unresponsive to Anti-Arrhythmia Agents Quantity | Symptoms | Palpitations | Dyspnea | Chest Pain | Fatigue | Ventricular Dysfunction, Left | Combination Symptoms
Item
patients with symptomatic af that is refractory to at least one antiarrhythmic medication. "symptomatic" patients are those who have been aware of their af anytime within the last 5 years prior to enrollment. symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
boolean
C0741283 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C1457887 (UMLS CUI [2])
C0030252 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0008031 (UMLS CUI [5])
C0015672 (UMLS CUI [6])
C0242698 (UMLS CUI [7])
C0205195 (UMLS CUI [8,1])
C1457887 (UMLS CUI [8,2])
Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Fibrillation Episode Quantity Holter Electrocardiography | Atrial Fibrillation Episode Quantity Loop recorder | Atrial Fibrillation Episode Quantity Telemetry | Other Coding
Item
at least one episode of af must have been documented by ecg, holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of entry in the trial.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,4])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0013801 (UMLS CUI [2,4])
C0004238 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3838353 (UMLS CUI [3,4])
C0004238 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0039451 (UMLS CUI [4,4])
C3846158 (UMLS CUI [5])
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 | Thyroid Disease | Status post Operative Surgical Procedures
Item
patients with af felt to be secondary to an obvious reversible cause (e.g. thyroid disease, post-surgical).
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
C0040128 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Direct Thrombin Inhibitor
Item
patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
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])
C3536847 (UMLS CUI [3,2])
Renal Insufficiency Severe | Creatinine clearance measurement
Item
patients with severe renal impairment (creatinine clearance of <30 ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Left atrium Size 2D Echocardiography Parasternal long axis view
Item
patients with left atrial size >/= 60 mm (2d echocardiography, parasternal long axis view).
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0013524 (UMLS CUI [1,3])
C1302222 (UMLS CUI [1,4])
Pregnancy | Possible pregnancy | Contraceptive methods Absent | Pregnancy, Planned
Item
patients who are or may potentially be pregnant or who are not on an effective method of birth control or who are planning to get pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0032992 (UMLS CUI [4])
HEART-VALVE, MECHANICAL
Item
patients with mechanical heart valves.
boolean
C0493527 (UMLS CUI [1])
Catheter ablation for atrial fibrillation Repeated
Item
patients who are undergoing repeat catheter ablation of af.
boolean
C2702800 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Manifestation Hemorrhagic | Bleeding tendency | Hemostasis Impairment
Item
patients with hemorrhagic manifestations, bleeding diathesis, or patients with impairment of hemostasis.
boolean
C0205319 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
C1458140 (UMLS CUI [2])
C0019116 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
Lesion Bleeding risk | Cerebral Infarction Extensive | Peptic Ulcer with Hemorrhage Recent
Item
lesions at risk of clinically significant bleeding - such as extensive cerebral infarction within the last 6 months, active peptic ulcer disease with recent bleeding.
boolean
C0221198 (UMLS CUI [1,1])
C3251812 (UMLS CUI [1,2])
C0007785 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C0030920 (UMLS CUI [3,1])
C0332287 (UMLS CUI [3,2])
C0019080 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
P-Glycoprotein Inhibitors Strong | Ketoconazole
Item
concomitant treatment with strong p-glycoprotein inhibitors, i.e. ketoconazole.
boolean
C3500483 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C0022625 (UMLS CUI [2])
Hypersensitivity Dabigatran | Hypersensitivity Dabigatran etexilate
Item
known hypersensitivity to dabigatran or dabigatran etexilate.
boolean
C0020517 (UMLS CUI [1,1])
C2348066 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1571583 (UMLS CUI [2,2])
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