Study of New Implantable Loop Recorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-06-30

Brief Summary

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The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).

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Detailed Description

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Conditions

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Tachyarrhythmias Syncope

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Open Label

SJM Confirm Device

Group Type EXPERIMENTAL

SJM Confirm

Intervention Type DEVICE

All patients in this study will receive the SJM Confirm device.

Interventions

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SJM Confirm

All patients in this study will receive the SJM Confirm device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias
* Patients who experience transient symptoms that may suggest a cardiac arrhythmia
* Patients who have been previously diagnosed with atrial fibrillation
* Patients who are suspected to have Atrial Fibrillation (AF) but AF has not been documented
* Patients who have provided written informed consent to participate in the study.

Exclusion Criteria

* Patients who are under the age of 18 years
* Patients who have a life expectancy less than 1 year
* Patients who are unable to comply with the follow-up schedule
* Patients who are currently implanted with a pacemaker or defibrillator
* Patients who the physician deems inappropriate for the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No