Study of New Implantable Loop Recorder

Abbott Medical Devices75 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Tachyarrhythmias Syncope

Interventions

SJM ConfirmDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Alaska Heart Institute

Anchorage, Alaska, United States

Arizona Arrhythmia Research

Scottsdale, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

St. Jude Hospital

Outcomes

Primary Outcomes

Sensitivity for R Waves During In-Clinic Recordings at Rest

The sensitivity was calculated for each recording and for each subject.

Time frame: 6 weeks

Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise

The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.

Time frame: 6 weeks

Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers

The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.

Time frame: 6 weeks

Positive Predictive Value (PPV) for In-Clinic Recordings at Rest

The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.

Time frame: 6 weeks

Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test

The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.

Time frame: 6 weeks

Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers

The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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