ID

37523

Beschrijving

Efficiency Study Evaluating the Use of the PVAC Catheter Technology for Performing Ablation in Patients With Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01562912

Link

https://clinicaltrials.gov/show/NCT01562912

Trefwoorden

Versies (1)
  1. 04-08-19 04-08-19 -
Houder van rechten

See clinicaltrials.gov

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4 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01562912

Engels

Eligibility Atrial Fibrillation NCT01562912

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 18 years or greater.
Beschrijving

Age

Datatype

boolean

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

Catheter ablation for atrial fibrillation Firstly

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1279901
patients with paroxysmal af. paroxysmal af will be defined as self-terminating episodes less than 7 days duration. patients should have had at least 3 episodes of af in a one year period.
Beschrijving

Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Episode Duration | Atrial Fibrillation Episode Quantity Year

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0449238
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0439234
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, or any combination of the above.
Beschrijving

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

Datatype

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 [7,1]
C0205195
UMLS CUI [7,2]
C1457887
at least one episode of af must have been documented by ecg, holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of enrollment in the study.
Beschrijving

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

Datatype

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 study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with persistent af (defined as an episode of af lasting >7 days).
Beschrijving

Persistent atrial fibrillation | Atrial Fibrillation Episode Duration

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0449238
patients with af felt to be secondary to an obvious reversible cause.
Beschrijving

Atrial Fibrillation Secondary to Cause Reversible

Datatype

boolean

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

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

Datatype

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]
C0043031
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C3536847
patients who have previously undergone af ablation.
Beschrijving

Catheter ablation for atrial fibrillation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
patients with left atrial size >/= 55 mm (2d echocardiography, parasternal long axis view).
Beschrijving

Left atrium Size 2D Echocardiography Parasternal long axis view

Datatype

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.
Beschrijving

Pregnancy | Possible pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
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Similar models

Eligibility Atrial Fibrillation NCT01562912

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged 18 years 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 | Paroxysmal atrial fibrillation Episode Duration | Atrial Fibrillation Episode Quantity Year
Item
patients with paroxysmal af. paroxysmal af will be defined as self-terminating episodes less than 7 days duration. patients should have had at least 3 episodes of af in a one year period.
boolean
C0235480 (UMLS CUI [1])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0439234 (UMLS CUI [3,4])
ATRIAL FIBRILLATION SYMPTOMATIC Unresponsive to Anti-Arrhythmia Agents Quantity | Symptoms | Palpitations | Dyspnea | Chest Pain | Fatigue | 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, 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])
C0205195 (UMLS CUI [7,1])
C1457887 (UMLS CUI [7,2])
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 enrollment in the study.
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 study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation | Atrial Fibrillation Episode Duration
Item
patients with persistent af (defined as an episode of af lasting >7 days).
boolean
C2585653 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Atrial Fibrillation Secondary to Cause Reversible
Item
patients with af felt to be secondary to an obvious reversible cause.
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Warfarin | Medical contraindication Direct Thrombin Inhibitor
Item
patients with contraindications to systemic anticoagulation with heparin or warfarin 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])
C0043031 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C3536847 (UMLS CUI [4,2])
Catheter ablation for atrial fibrillation Previous
Item
patients who have previously undergone af ablation.
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Left atrium Size 2D Echocardiography Parasternal long axis view
Item
patients with left atrial size >/= 55 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
Item
patients who are or may potentially be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
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