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Pacemaker technology is constantly evolving. In the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. These advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (RF) technology. However, little information is available on how these new features are being utilized by physicians in the real world and how these features impact patient outcomes.
This observational study will gather data on the patients' presenting clinical status, indication for device implantation, utilization of advanced device features, device therapy choices, clinical management and outcomes in a general pacemaker population.
The primary aim of the study is to evaluate the usage of advanced features and diagnostics in patients with St. Jude Medical pacemakers. The secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. The tertiary aim of the study is to evaluate the correlation between the usage of advanced features in pacemaker patients and the patient's clinical outcomes.
Evaluation of Device Features and Diagnostics
Evaluation of Clinical Parameters
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| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate at 1-year Post-implant | Complication rate and 95% confidence interval at 1-year post-implant | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for standard Pacemaker indications
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| Name | Affiliation | Role |
|---|---|---|
| Grant Kim | Abbott (previously St. Jude Medical) | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Enrolled in the Study | Patients implanted with an SJM Accent SR/DR, Accent SR/DR RF, Anthem CRT-P, Anthem CRT-P RF, or newer SJM pacemaker device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Enrolled in the Study | All subjects that were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Complication Rate at 1-year Post-implant | Complication rate and 95% confidence interval at 1-year post-implant | All subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | percentage of enrolled subjects | 12 months |
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Adverse events reported during the 1-year study.
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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 | All Subjects Enrolled in the Study | All subjects that were enrolled in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead dislodgement or migration | Product Issues | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated pacing thresholds | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim | Abbott (Previously St Jude Medical) | 818-493-3147 | grant.kim1@abbott.com |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary Indication for Pacemaker Implant | Count of Participants | Participants |
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| Cardiovascular History | Count of Participants | Participants |
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| Ejection Fraction | Mean | Standard Deviation | % of blood leaving heart at contraction |
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| Other Medical History | Count of Participants | Participants |
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| Medications | Count of Participants | Participants |
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| Systolic BP | Mean | Standard Deviation | mm Hg |
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| Diastolic BP | Mean | Standard Deviation | mm Hg |
|
| Heart Rate | Mean | Standard Deviation | beats per min (bpm) |
|
|
| 209 |
| 3,389 |
| 38 |
| 3,389 |
| 17 |
| 3,389 |
| Infection | Infections and infestations | Systematic Assessment |
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| Elevated pacing thresholds | Product Issues | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Bleeding/Hematoma | Gastrointestinal disorders | Systematic Assessment |
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| Diaphragmatic/Phrenic Nerve Stimulation | Product Issues | Systematic Assessment |
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| Dehisence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Lead Malfunction | Product Issues | Systematic Assessment |
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| Lead fracture | Product Issues | Systematic Assessment |
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| Loss of capture | Product Issues | Systematic Assessment |
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| Mid-sternal pain at the location of RA and RV leads | Injury, poisoning and procedural complications | Systematic Assessment |
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| Open wound at PG incision site | Injury, poisoning and procedural complications | Systematic Assessment |
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| Oversensing | Product Issues | Systematic Assessment |
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| Pericardial effusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pericardial tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pocket Revision- not Healing | Injury, poisoning and procedural complications | Systematic Assessment |
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| Set Screw not secured at Implant | Injury, poisoning and procedural complications | Systematic Assessment |
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| Oversensing | Product Issues | Systematic Assessment |
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| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Inappropriate device interaction | Product Issues | Systematic Assessment |
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| Loss of capture | Product Issues | Systematic Assessment |
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| Syncope | Vascular disorders | Systematic Assessment |
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| Hematoma | Vascular disorders | Systematic Assessment |
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