ID

12027

Beschrijving

PVI Using Cryoablation Alone in Paroxysmal AF Patients Converted From Persistent AF With Dofetilide; ODM derived from: https://clinicaltrials.gov/show/NCT01877486 Principal Investigator: Jonathan S Steinberg, MD University of Rochester

Link

https://clinicaltrials.gov/show/NCT01877486

Trefwoorden

Versies (1)
  1. 01-09-15 01-09-15 -
Geüploaded op

1 september 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT01877486

Engels

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Aged 18 to 80 years
Beschrijving

Aged 18 to 80 years

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Able and willing to give written informed consent
Beschrijving

Able and willing to give written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
Beschrijving

Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings

Datatype

boolean

Alias
UMLS CUI [1]
C2945760
UMLS CUI [2]
C0235480
Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide
Beschrijving

Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Previous ablation for AF
Beschrijving

Previous ablation for AF

Datatype

boolean

Alias
UMLS CUI [1]
C2702800
Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
Beschrijving

Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)

Datatype

boolean

Alias
UMLS CUI [1]
C2825176
Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
Beschrijving

Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)

Datatype

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0205375
Presence of severe valvular disease with the need for surgical correction
Beschrijving

Presence of severe valvular disease with the need for surgical correction

Datatype

boolean

Alias
UMLS CUI [1]
C3258293
AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
Beschrijving

AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0175668
UMLS CUI [2]
C1704258
Pregnant women or women of child bearing potential and not on reliable methods of birth control
Beschrijving

Pregnant women or women of child bearing potential and not on reliable methods of birth control

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
Second or third degree AV block, sinus pause > 3 seconds, resting heart rate< 30 bpm without permanent pacemaker
Beschrijving

Second or third degree AV block, sinus pause > 3 seconds, resting heart rate< 30 bpm without permanent pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0741311
History of drug-induced Torsades de Pointes or congenital long QT syndrome
Beschrijving

History of drug-induced Torsades de Pointes or congenital long QT syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0040479
UMLS CUI [2]
C0458082
Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.
Beschrijving

Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C3843614
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
Aged 18 to 80 years
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
Able and willing to give written informed consent
boolean
C0021430 (UMLS CUI [1])
recurrent; Paroxysmal atrial fibrillation
Item
Paroxysmal AF, defined as recurrent AF ( ≥ 2 episodes in 1 month) that terminates within 7 days as assessed by ECG recordings
boolean
C2945760 (UMLS CUI [1])
C0235480 (UMLS CUI [2])
Paroxysmal atrial fibrillation
Item
Prior persistent AF, defined as sustained beyond seven days and up to one year, successfully converted to paroxysmal AF by dofetilide
boolean
C0235480 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
ablation for AF
Item
Previous ablation for AF
boolean
C2702800 (UMLS CUI [1])
Left Atrium Size, Quantitative
Item
Left atrial size larger than 60mm (parasternal view on transthoracic echocardiogram)
boolean
C2825176 (UMLS CUI [1])
Cardiac Arrhythmia; Uniform
Item
Patients who have AF episodes triggered by another uniform arrhythmia (e.g. atrial flutter or atrial tachycardia)
boolean
C0003811 (UMLS CUI [1])
C0205375 (UMLS CUI [2])
valvular disease
Item
Presence of severe valvular disease with the need for surgical correction
boolean
C3258293 (UMLS CUI [1])
secondary; abnormality
Item
AF deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy
boolean
C0175668 (UMLS CUI [1])
C1704258 (UMLS CUI [2])
pregnant women
Item
Pregnant women or women of child bearing potential and not on reliable methods of birth control
boolean
C0549206 (UMLS CUI [1])
AV BLOCK HIGH DEGREE
Item
Second or third degree AV block, sinus pause > 3 seconds, resting heart rate< 30 bpm without permanent pacemaker
boolean
C0741311 (UMLS CUI [1])
Torsades de Pointes;Drug-induced
Item
History of drug-induced Torsades de Pointes or congenital long QT syndrome
boolean
C0040479 (UMLS CUI [1])
C0458082 (UMLS CUI [2])
Atrial Fibrillation; Uninterrupted
Item
Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for ≥ 24 hours after cardioversion.
boolean
C0004238 (UMLS CUI [1])
C3843614 (UMLS CUI [2])
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