ID

12027

Description

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

Keywords

Versions (1)
  1. 9/1/15 9/1/15 -
Uploaded on

September 1, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT01877486

English

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Aged 18 to 80 years

Data type

boolean

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

Able and willing to give written informed consent

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0235480
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Previous ablation for AF
Description

Previous ablation for AF

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Presence of severe valvular disease with the need for surgical correction

Data type

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
Description

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

Data type

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
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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.
Description

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

Data type

boolean

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

Eligibility Paroxysmal Atrial Fibrillation NCT01877486

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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