ID

12027

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01877486

Nyckelord

Versioner (1)
  1. 2015-09-01 2015-09-01 -
Uppladdad den

1 september 2015

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT01877486

Engelsk

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Aged 18 to 80 years

Datatyp

boolean

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

Able and willing to give written informed consent

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0235480
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Previous ablation for AF
Beskrivning

Previous ablation for AF

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

Presence of severe valvular disease with the need for surgical correction

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

boolean

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

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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