Syncope, Tachyarrhythmias
Conditions
Keywords
Implantable Cardiac Monitor, Arrhythmias, Atrial Fibrillation
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).
Interventions
DEVICESJM Confirm
All patients in this study will receive the SJM Confirm device.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| Sensitivity for R Waves During In-Clinic Recordings at Rest | 6 weeks | The sensitivity was calculated for each recording and for each subject. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Interpretability of Automatically Triggered/Symptom Driven Recordings | 6 weeks | The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject. |
| Inappropriateness of Automatically Triggered Recordings - Phase I | 6 weeks | 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. |
| Inappropriateness of Automatically Triggered Recordings - Phase II | 6 weeks | 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. |
| Interpretability of Weekly Subject Activator Recordings | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label All patients who were implanted with the SJM Confirm device. | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Required Pacemaker/ICD Implant | 2 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Continuous | 62 years |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 75 |
| serious Total, serious adverse events | 11 / 75 |
Outcome results
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers | 85.0 percentage of recordings |
Comparison: 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 recording95% CI: [78.3, 91.7]
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Positive Predictive Value (PPV) for In-Clinic Recordings at Rest | 98.9 percentage of recordings |
Comparison: 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 recording95% CI: [96.7, 100]
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test | 77.1 percentage of recordings |
Comparison: 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 recording95% CI: [65.9, 88.4]
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Sensitivity for R Waves During In-Clinic Recordings at Rest | 100 percentage of recordings |
Comparison: 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 ECG95% CI: [100, 100]
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers | 98.0 percentage of recordings |
Comparison: 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 ECG95% CI: [95.5, 100]
Primary
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise | 98.1 percentage of recordings |
Comparison: 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 ECG95% CI: [95.7, 100]
Other Pre-specified
Inappropriateness of Automatically Triggered Recordings - Phase I
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Inappropriateness of Automatically Triggered Recordings - Phase I | 86.2 percentage of inappropriate recordings |
95% CI: [79.4, 91]
Other Pre-specified
Inappropriateness of Automatically Triggered Recordings - Phase II
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Inappropriateness of Automatically Triggered Recordings - Phase II | 62.3 percentage of inappropriate recordings |
95% CI: [48.1, 76.2]
Other Pre-specified
Interpretability of Automatically Triggered/Symptom Driven Recordings
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Interpretability of Automatically Triggered/Symptom Driven Recordings | 92.3 percentage of interpretable recordings |
Comparison: 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 time95% CI: [91.9, 92.6]
Other Pre-specified
Interpretability of Weekly Subject Activator Recordings
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| SJM Confirm Device | Interpretability of Weekly Subject Activator Recordings | 99.2 percentage of interpretable recordings |
Comparison: 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)95% CI: [98.5, 100]