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Study of New Implantable Loop Recorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00746564
Recruitment Status : Completed
First Posted : September 4, 2008
Results First Posted : April 30, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Tachyarrhythmias
Syncope
Intervention Device: SJM Confirm
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description All patients in this study received the St. Jude Medical (SJM Confirm device.
Period Title: Overall Study
Started 75
Completed 73
Not Completed 2
Reason Not Completed
Required Pacemaker/ICD Implant             2
Arm/Group Title Open Label
Hide Arm/Group Description All patients who were implanted with the SJM Confirm device.
Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
All patients implanted with the Confirm Device.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 75 participants
62
(19 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
31
  41.3%
Male
44
  58.7%
1.Primary Outcome
Title Sensitivity for R Waves During In-Clinic Recordings at Rest
Hide Description The sensitivity was calculated for each recording and for each subject.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 48
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical recordings
88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
100
(100 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The sensitivity was calculated for each recording and for each subject as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of recordings
Estimated Value 100
Confidence Interval (2-Sided) 95%
100 to 100
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 46
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical Recordings
39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
98.1
(95.7 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of clinical recordings
Estimated Value 98.1
Confidence Interval (2-Sided) 95%
95.7 to 100
Estimation Comments [Not Specified]
3.Primary Outcome
Title Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 48
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical Recordings
82
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
98.0
(95.5 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of recordings
Estimated Value 98.0
Confidence Interval (2-Sided) 95%
95.5 to 100
Estimation Comments [Not Specified]
4.Primary Outcome
Title Positive Predictive Value (PPV) for In-Clinic Recordings at Rest
Hide Description The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 48
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical Recordings
89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
98.9
(96.7 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of recordings
Estimated Value 98.9
Confidence Interval (2-Sided) 95%
96.7 to 100
Estimation Comments [Not Specified]
5.Primary Outcome
Title Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test
Hide Description The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 45
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical recordings
45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
77.1
(65.9 to 88.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of recording
Estimated Value 77.1
Confidence Interval (2-Sided) 95%
65.9 to 88.4
Estimation Comments [Not Specified]
6.Primary Outcome
Title Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 48
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical Recordings
92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of recordings
85.0
(78.3 to 91.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:

Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of recordings
Estimated Value 85.0
Confidence Interval (2-Sided) 95%
78.3 to 91.7
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Interpretability of Weekly Subject Activator Recordings
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients in this study received the SJM Confirm device.
Overall Number of Participants Analyzed 30
Overall Number of Units Analyzed
Type of Units Analyzed: Clinical Recordings
58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of interpretable recordings
99.2
(98.5 to 100)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:

Duration (sec) of interpretable recording / Total duration of recording time (sec)

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of interpretable recording
Estimated Value 99.2
Confidence Interval (2-Sided) 95%
98.5 to 100
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Interpretability of Automatically Triggered/Symptom Driven Recordings
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients implanted with an SJM Confirm device.
Overall Number of Participants Analyzed 47
Overall Number of Units Analyzed
Type of Units Analyzed: Recordings
2804
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of interpretable recordings
92.3
(91.9 to 92.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments

The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:

Duration of interpretable recording / Total duration of recording time

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of interpretable recording
Estimated Value 92.3
Confidence Interval (2-Sided) 95%
91.9 to 92.6
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Inappropriateness of Automatically Triggered Recordings - Phase I
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients implanted with an SJM Confirm device.
Overall Number of Participants Analyzed 47
Overall Number of Units Analyzed
Type of Units Analyzed: Recordings
2741
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of inappropriate recordings
86.2
(79.4 to 91.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of inappropriate recordings
Estimated Value 86.2
Confidence Interval (2-Sided) 95%
79.4 to 91.0
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Inappropriateness of Automatically Triggered Recordings - Phase II
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description:
All patients implanted with the SJM Confirm device.
Overall Number of Participants Analyzed 36
Overall Number of Units Analyzed
Type of Units Analyzed: Recording
958
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of inappropriate recordings
62.3
(48.1 to 76.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SJM Confirm Device
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of inappropriate recordings
Estimated Value 63.2
Confidence Interval (2-Sided) 95%
48.1 to 76.2
Estimation Comments [Not Specified]
Time Frame Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years.
Adverse Event Reporting Description Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
 
Arm/Group Title SJM Confirm Device
Hide Arm/Group Description All patients in this study received the SJM Confirm device.
All-Cause Mortality
SJM Confirm Device
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
SJM Confirm Device
Affected / at Risk (%) # Events
Total   11/75 (14.67%)    
Surgical and medical procedures   
PREMATURE BATTERY DEPLETION/ ICM   10/75 (13.33%)  10
DEVICE EXTRUSION   1/75 (1.33%)  1
VAGAL REACTION   1/75 (1.33%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SJM Confirm Device
Affected / at Risk (%) # Events
Total   14/75 (18.67%)    
Surgical and medical procedures   
EARLY BATTERY DEPLETION/ PATIENT ACTIVATOR   4/75 (5.33%)  4
Excessive Noise on the EGM Resulting in Inability to Interpret the EGM   7/75 (9.33%)  12
Undersensing   9/75 (12.00%)  14
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Studies
Organization: St. Jude Medical
Phone: 1-800-733-3455
EMail: tshipman@sjm.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00746564    
Other Study ID Numbers: 60020941D
First Submitted: September 2, 2008
First Posted: September 4, 2008
Results First Submitted: April 13, 2015
Results First Posted: April 30, 2015
Last Update Posted: January 30, 2019