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Study of New Implantable Loop Recorder

Primary Purpose

Tachyarrhythmias, Syncope

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SJM Confirm
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tachyarrhythmias focused on measuring Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Heart Institute
  • Arizona Arrhythmia Research
  • Arkansas Heart Hospital
  • St. Jude Hospital
  • Scripps Clinic
  • Oklahoma Heart Institute at Utica
  • Providence- St Vincent Medical Center
  • Texas Cardiac Arrhythmia Research Foundation
  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

SJM Confirm Device

Outcomes

Primary Outcome Measures

Sensitivity for R Waves During In-Clinic Recordings at Rest
The sensitivity was calculated for each recording and for each subject.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2008
Last Updated
January 28, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00746564
Brief Title
Study of New Implantable Loop Recorder
Official Title
Confirm Implantable Cardiac Monitor Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachyarrhythmias, Syncope
Keywords
Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
SJM Confirm Device
Intervention Type
Device
Intervention Name(s)
SJM Confirm
Intervention Description
All patients in this study will receive the SJM Confirm device.
Primary Outcome Measure Information:
Title
Sensitivity for R Waves During In-Clinic Recordings at Rest
Description
The sensitivity was calculated for each recording and for each subject.
Time Frame
6 weeks
Title
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
Description
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Time Frame
6 weeks
Title
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
Description
The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.
Time Frame
6 weeks
Title
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
Description
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Time Frame
6 weeks
Title
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
Description
The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Time Frame
6 weeks
Title
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
Description
The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Interpretability of Weekly Subject Activator Recordings
Description
The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.
Time Frame
6 weeks
Title
Interpretability of Automatically Triggered/Symptom Driven Recordings
Description
The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.
Time Frame
6 weeks
Title
Inappropriateness of Automatically Triggered Recordings - Phase I
Description
The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.
Time Frame
6 weeks
Title
Inappropriateness of Automatically Triggered Recordings - Phase II
Description
The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Shipman
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Heart Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Arrhythmia Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
St. Jude Hospital
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-2605
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Oklahoma Heart Institute at Utica
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence- St Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22980
Country
United States

12. IPD Sharing Statement

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Study of New Implantable Loop Recorder

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