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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | SJM Confirm Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJM Confirm | Device | All patients in this study will receive the SJM Confirm device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for R Waves During In-Clinic Recordings at Rest | The sensitivity was calculated for each recording and for each subject. | 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. | 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. | 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. | 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. | 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. | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Interpretability of Automatically Triggered/Symptom Driven Recordings |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Shipman | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | 99508 | United States | ||
| Arizona Arrhythmia Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | SJM Confirm Device | All patients in this study received the St. Jude Medical (SJM Confirm device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients implanted with the Confirm Device.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | All patients who were implanted with the SJM Confirm device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity for R Waves During In-Clinic Recordings at Rest | The sensitivity was calculated for each recording and for each subject. | 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). | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical recordings | Clinical recordings |
|
|
Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years.
Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SJM Confirm Device | All patients in this study received the SJM Confirm device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PREMATURE BATTERY DEPLETION/ ICM | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EARLY BATTERY DEPLETION/ PATIENT ACTIVATOR | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Studies | St. Jude Medical | 1-800-733-3455 | tshipman@sjm.com |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D013575 | Syncope |
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
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The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject. |
| 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| St. Jude Hospital | Fullerton | California | 92835-2605 | United States |
| Scripps Clinic | La Jolla | California | 92037 | United States |
| Oklahoma Heart Institute at Utica | Tulsa | Oklahoma | 74104 | United States |
| Providence- St Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| University of Virginia | Charlottesville | Virginia | 22980 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
| Clinical recordings |
|
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical Recordings | Clinical Recordings |
|
|
|
|
| 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. | 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 | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical Recordings | Clinical Recordings |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical Recordings | Clinical Recordings |
|
|
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical recordings | Clinical recordings |
|
|
|
|
| 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. | 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) | Posted | Number | 95% Confidence Interval | percentage of recordings | 6 weeks | Clinical Recordings | Clinical Recordings |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of interpretable recordings | 6 weeks | Clinical Recordings | Clinical Recordings |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of interpretable recordings | 6 weeks | Recordings | Recordings |
|
|
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of inappropriate recordings | 6 weeks | Recordings | Recordings |
|
|
|
|
| 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. | 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 | Posted | Number | 95% Confidence Interval | percentage of inappropriate recordings | 6 weeks | Recording | Recording |
|
|
|
|
| 11 |
| 75 |
| 14 |
| 75 |
| DEVICE EXTRUSION | Surgical and medical procedures | Systematic Assessment |
|
| VAGAL REACTION | Surgical and medical procedures | Systematic Assessment |
|
| Excessive Noise on the EGM Resulting in Inability to Interpret the EGM | Surgical and medical procedures | Systematic Assessment |
|
| Undersensing | Surgical and medical procedures | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |