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The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Other | Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. |
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| Risk Status Guided | Experimental | Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal XT® Insertable Cardiac Monitor | Device | If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score. | 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm) |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation of HFRS Status With Actions/Testing | At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms. Because of the small number of subjects randomized, no formal statistical analyses were performed. | 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| IDENTIFY-HF Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green | La Jolla | California | 92037 | United States | ||
| Aurora Denver Cardiology Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | The Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Heart Failure Risk Status Diagnostic | Other | The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
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| Clinical Status Measures | Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst)) Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate. | 0 to 18 months post-implant |
| Aurora |
| Colorado |
| 80012 |
| United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Carolinas Medical Center/Sanger Heart & Vascular | Charlotte | North Carolina | 28203 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Lancaster Heart & Stroke Foundation | Lancaster | Pennsylvania | 17602 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| St. Thomas Research Institute | Nashville | Tennessee | 37205 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Heart Clinic PLLC | McAllen | Texas | 78503 | United States |
| FG001 | Risk Status Guided | Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
| FG002 | No Implant | Subjects who did not undergo an implant attempt and were not randomized. |
| FG003 | Implanted Not Randomized | Subject were implanted and not randomized |
| COMPLETED | 18 Month/Exit Visit |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
| BG001 | Risk Status Guided | Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
| BG002 | Not Randomized | Subjects who were not randomized |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| New York Heart Assocation (NYHA) Functional Classification | NYHA Class is a measure of a patient's degree of heart failure with 4 possible scores, ranging from I to IV. The classifications and 2015 definitions are as follows: I: No limitation of physical activity. II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea. III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. | Number | number |
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| LVEF | Mean | Standard Deviation | percentage |
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| Heart Failure Stage | Number | Participants |
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| 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 | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score. | Posted | Number | participants | 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm) |
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| Other Pre-specified | Correlation of HFRS Status With Actions/Testing | At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms. Because of the small number of subjects randomized, no formal statistical analyses were performed. | Only randomized subjects who did not exit prior to the period in which clinicians could utilized the HFRS score (6-18 months for HFRS Guided Arm, 13-18 months for Control Arm) were included in the analysis. | Posted | Number | Visits with high/very high score | 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm) | Visits with High/Very High HFRS Score | Visits with High/Very High HFRS Score |
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| Other Pre-specified | Clinical Status Measures | Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst)) Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate. | Subjects randomized to the Risk Status Guided Arm | Posted | Count of Units | Outcome of Patients During Guided Period | No | 0 to 18 months post-implant | Outcome of Patients During Guided Period | Outcome of Patients During Guided Period |
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Adverse events were collected from the point of enrollment to the completion of follow-up (18 months).
All subjects were assessed for adverse events through their follow-up visits as well as unscheduled visits as the adverse events occurred.
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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 | Control Arm | Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status.The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". | 0 | 7 | 6 | 7 | 6 | 7 |
| EG001 | Risk Status Guided | Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". | 0 | 10 | 5 | 10 | 7 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Unstable Angina | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Atrial Fribrillation | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Chest Pain | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
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| International normalizes ratio decreased | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Pulmonary Vascular Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Sick Sinus Syndrome | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardogenic Shock | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Renal Failure Acute | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fribillation | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Drug Intolerance | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| Hyperkalaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Chest Discomfort | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Rose, Clinical Research Specialist | Medtronic, Inc | 763-526-2332 | rachael.k.rose@medtronic.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| NYHA Class III |
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| Not available |
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| HF Event(s), No High/Very High Score |
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| No High/Very High Score or HF Event(s) |
|
| OG001 | Risk Status Guided | Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location). Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
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| OG001 | Control Arm | The Control arm will be observed between months 13-18, and so only Control arm subjects followed beyond 12 months are included. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location), but study doctors for the subjects will have access to the risk status. Heart Failure Risk Status Diagnostic: The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity. Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: "Low", "Medium", "High", or "Very High". |
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