Study of New Implantable Loop Recorder

Not Applicable

Completed

• Conditions: Tachyarrhythmias; Syncope
• Interventions: Device: SJM Confirm

• Registration Number: NCT00746564
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Primary Completion: 2011-02
• Disposition First Submitted: 2012-08-24
• Disposition First Submitted QC: 2012-08-24
• Disposition First Posted: 2012-08-31
• Study Completion: 2014-06
• Results First Submitted: 2015-04-13
• Results First Submitted QC: 2015-04-13
• Results First Posted: 2015-04-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	SJM Confirm	SJM Confirm Device

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test	6 weeks	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers	6 weeks	The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings at Rest	6 weeks	The sensitivity was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise	6 weeks	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers	6 weeks	The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest	6 weeks	The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.

Trial Locations

Locations (9)

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Alaska Heart Institute; 🇺🇸 Anchorage, Alaska, United States

Arizona Arrhythmia Research; 🇺🇸 Scottsdale, Arizona, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

St. Jude Hospital; 🇺🇸 Fullerton, California, United States

Oklahoma Heart Institute at Utica; 🇺🇸 Tulsa, Oklahoma, United States

Providence- St Vincent Medical Center; 🇺🇸 Portland, Oregon, United States