ID

36428

Description

Comparison of External Event Recorders for Atrial Fibrillation Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT00863382 Brief Summary: Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias. Often times, it is very inconvenient for patients to wear external event recorders. Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort. However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience. In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.

Link

https://clinicaltrials.gov/show/NCT00863382

Keywords

  1. 1/14/19 1/14/19 - Julian Varghese
  2. 5/14/19 5/14/19 -
Copyright Holder

Dhanunjaya Lakkireddy, MD, FACC

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0

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External Event Recorders in Atrial Fibrillation NCT00863382

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant undergo radiofrequency ablation of paroxysmal AF?
Description

All subjects who undergo radiofrequency ablation of paroxysmal af can be considered (see exclusion criteria)

Data type

boolean

Alias
UMLS CUI [1,1]
C0235480
UMLS CUI [1,2]
C0162561
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Does the participant have a known allergy to sticky patches of event monitors?
Description

Patch allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2825163
UMLS CUI [1,3]
C4047918
Does the participant have skin infection or other problems on the chest that interferes with monitor implantation?
Description

Interference with monitor Implantation

Data type

boolean

Alias
UMLS CUI [1,1]
C2825163
UMLS CUI [1,2]
C0037278
UMLS CUI [1,3]
C0521102
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0817096
UMLS CUI [2,3]
C0205394
Is the participant scheduled for radiation therapy?
Description

Radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205539
Is the participant scheduled for therapeutic ultrasound (like lithotripsy)?
Description

Therapeutic ultrasound

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1456803
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0023878
Is the participant scheduled for MRI?
Description

MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0205539
Is the participant scheduled for a procedure that uses diathermy?
Description

Diathermy

Data type

boolean

Alias
UMLS CUI [1,1]
C0012002
UMLS CUI [1,2]
C0205539
Is the participant in the opinion of the investigator, not a suitable candidate for the study?
Description

Suitability

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
Does the participant not have an analog telephone line at home?
Description

Phone availability

Data type

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C0470187
Does the participant have an existing cardiac rhythm management device (e.g., pacemaker or icd)?
Description

Cardiac rythm management device

Data type

boolean

Alias
UMLS CUI [1,1]
C2735362
UMLS CUI [1,2]
C0018787
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0810515

Similar models

Eligibility Criteria

  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Radiofrequency Ablation of Atrial Fibrillation
Item
Does the participant undergo radiofrequency ablation of paroxysmal AF?
boolean
C0235480 (UMLS CUI [1,1])
C0162561 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Patch allergy
Item
Does the participant have a known allergy to sticky patches of event monitors?
boolean
C0020517 (UMLS CUI [1,1])
C2825163 (UMLS CUI [1,2])
C4047918 (UMLS CUI [1,3])
Interference with monitor Implantation
Item
Does the participant have skin infection or other problems on the chest that interferes with monitor implantation?
boolean
C2825163 (UMLS CUI [1,1])
C0037278 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1254481 (UMLS CUI [2,1])
C0817096 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
Radiation therapy
Item
Is the participant scheduled for radiation therapy?
boolean
C1522449 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Therapeutic ultrasound
Item
Is the participant scheduled for therapeutic ultrasound (like lithotripsy)?
boolean
C0087111 (UMLS CUI [1,1])
C1456803 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0023878 (UMLS CUI [2])
MRI
Item
Is the participant scheduled for MRI?
boolean
C0024485 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Diathermy
Item
Is the participant scheduled for a procedure that uses diathermy?
boolean
C0012002 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
Suitability
Item
Is the participant in the opinion of the investigator, not a suitable candidate for the study?
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Phone availability
Item
Does the participant not have an analog telephone line at home?
boolean
C0039457 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
Cardiac rythm management device
Item
Does the participant have an existing cardiac rhythm management device (e.g., pacemaker or icd)?
boolean
C2735362 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0810515 (UMLS CUI [3])

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