DEtermining Accuracy and TrEnding CharacTerization of AF

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SJM Confirm ICM Observational Group

SJM Confirm ICM

Intervention Type DEVICE

Interventions

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SJM Confirm ICM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject has been implanted with a SJM Confirm ICM, DM2102.
* The subject has or is suspected to have paroxysmal AF.
* The subject is ≥ 18 years of age.
* The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

Exclusion Criteria

* The subject has persistent (\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \>1 year) or permanent AF (not attempting to restore sinus rhythm).
* The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
* The subject has a contraindication to Holter recording.
* The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
* The subject is unable to comply with the follow up schedule.
* The subject is participating in another investigational device or drug investigation.
* The subject is pregnant or is planning to become pregnant during the duration of the investigation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No