Trial Outcomes & Findings for Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure (NCT NCT01486316)
NCT ID: NCT01486316
Last Updated: 2018-07-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
Results posted on
2018-07-12
Participant Flow
Participant milestones
| Measure |
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".
|
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".
|
No Implant
Subjects who did not undergo an implant attempt and were not randomized.
|
Implanted Not Randomized
Subject were implanted and not randomized
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
5
|
2
|
|
Overall Study
COMPLETED
|
3
|
7
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
5
|
2
|
Reasons for withdrawal
| Measure |
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".
|
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".
|
No Implant
Subjects who did not undergo an implant attempt and were not randomized.
|
Implanted Not Randomized
Subject were implanted and not randomized
|
|---|---|---|---|---|
|
Overall Study
Device explanted with/without re-implant
|
3
|
2
|
0
|
2
|
|
Overall Study
Not meeting eligibility criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
Baseline characteristics by cohort
| Measure |
Control Arm
n=7 Participants
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".
|
Risk Status Guided
n=10 Participants
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".
|
Not Randomized
n=7 Participants
Subjects who were not randomized
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 7.6 • n=93 Participants
|
66.2 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
70.3 years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
69.9 years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
New York Heart Assocation (NYHA) Functional Classification
NYHA Class II
|
5 number
n=93 Participants
|
6 number
n=4 Participants
|
3 number
n=27 Participants
|
14 number
n=483 Participants
|
|
New York Heart Assocation (NYHA) Functional Classification
NYHA Class III
|
2 number
n=93 Participants
|
4 number
n=4 Participants
|
4 number
n=27 Participants
|
10 number
n=483 Participants
|
|
LVEF
|
60.0 percentage
STANDARD_DEVIATION 4.1 • n=93 Participants
|
60.2 percentage
STANDARD_DEVIATION 10.7 • n=4 Participants
|
50.6 percentage
STANDARD_DEVIATION 11.6 • n=27 Participants
|
57.3 percentage
STANDARD_DEVIATION 10.2 • n=483 Participants
|
|
Heart Failure Stage
Stage C
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Heart Failure Stage
Not available
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)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.
Outcome measures
| Measure |
Control Arm
n=7 Participants
The Control arm will be observed between months 13-18. 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".
|
Risk Status Guided
n=10 Participants
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".
|
|---|---|---|
|
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
High/Very High Score & HF Event(s)
|
5 participants
|
2 participants
|
|
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
High/Very High Score, No HF Event(s)
|
2 participants
|
7 participants
|
|
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
HF Event(s), No High/Very High Score
|
0 participants
|
0 participants
|
|
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
No High/Very High Score or HF Event(s)
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)Population: 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.
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.
Outcome measures
| Measure |
Control Arm
n=3 Visits with High/Very High HFRS Score
The Control arm will be observed between months 13-18. 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".
|
Risk Status Guided
n=58 Visits with High/Very High HFRS Score
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".
|
|---|---|---|
|
Correlation of HFRS Status With Actions/Testing
Significant Weight Gain Reported
|
0 Visits with high/very high score
|
9 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
High Blood Pressure
|
0 Visits with high/very high score
|
5 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
HF Symptoms Reported
|
1 Visits with high/very high score
|
46 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Medications Adjusted due to HFRS Score
|
1 Visits with high/very high score
|
18 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Rate Control Meds Adjusted due to HFRS Score
|
0 Visits with high/very high score
|
1 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Blood Pressure Meds Adjusted due to HFRS Score
|
0 Visits with high/very high score
|
4 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Diuretics Adjusted due to HFRS Score
|
1 Visits with high/very high score
|
15 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Directed to Clinic
|
0 Visits with high/very high score
|
9 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Directed to Emergency Department
|
0 Visits with high/very high score
|
0 Visits with high/very high score
|
|
Correlation of HFRS Status With Actions/Testing
Directed to Hospital
|
0 Visits with high/very high score
|
0 Visits with high/very high score
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 18 months post-implantPopulation: Subjects randomized to the Risk Status Guided Arm
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.
Outcome measures
| Measure |
Control Arm
n=25 Outcome of Patients During Guided Period
The Control arm will be observed between months 13-18. 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".
|
Risk Status Guided
n=2 Outcome of Patients During Guided Period
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".
|
|---|---|---|
|
Clinical Status Measures
HF Event During Guided Period
|
6 Outcome of Patients During Guided Period
|
1 Outcome of Patients During Guided Period
|
|
Clinical Status Measures
High/Very High HFRS Score During Guided Period
|
7 Outcome of Patients During Guided Period
|
1 Outcome of Patients During Guided Period
|
|
Clinical Status Measures
Quality of Life Improvement During Guided Period
|
5 Outcome of Patients During Guided Period
|
0 Outcome of Patients During Guided Period
|
|
Clinical Status Measures
6 Minute Hall Walk Improved During Guided Period
|
3 Outcome of Patients During Guided Period
|
0 Outcome of Patients During Guided Period
|
|
Clinical Status Measures
Improved NYHA During Guided Period
|
4 Outcome of Patients During Guided Period
|
0 Outcome of Patients During Guided Period
|
Adverse Events
Control Arm
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Risk Status Guided
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Arm
n=7 participants at risk
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".
|
Risk Status Guided
n=10 participants at risk
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".
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
14.3%
1/7 • Number of events 1 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Unstable Angina
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Cardiac disorders
Atrial Fribrillation
|
28.6%
2/7 • Number of events 2 • 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.
|
20.0%
2/10 • Number of events 3 • 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.
|
|
Cardiac disorders
Cardiac Failure
|
14.3%
1/7 • Number of events 1 • 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.
|
40.0%
4/10 • Number of events 4 • 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.
|
|
Cardiac disorders
Chest Pain
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Vascular disorders
Deep Vein Thrombosis
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Cardiac disorders
International normalizes ratio decreased
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.3%
1/7 • Number of events 1 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Vascular Disorder
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardogenic Shock
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Endocrine disorders
Renal Failure Acute
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 3 • 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.
|
Other adverse events
| Measure |
Control Arm
n=7 participants at risk
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".
|
Risk Status Guided
n=10 participants at risk
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".
|
|---|---|---|
|
Cardiac disorders
Atrial Fribillation
|
57.1%
4/7 • Number of events 6 • 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.
|
40.0%
4/10 • Number of events 4 • 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.
|
|
Cardiac disorders
Cardiac Failure
|
42.9%
3/7 • Number of events 7 • 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.
|
30.0%
3/10 • Number of events 3 • 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.
|
|
Metabolism and nutrition disorders
Drug Intolerance
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Blood and lymphatic system disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Chest Discomfort
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
General disorders
Cough
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Syncope
|
0.00%
0/7 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/7 • 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.
|
20.0%
2/10 • Number of events 2 • 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.
|
Additional Information
Rachael Rose, Clinical Research Specialist
Medtronic, Inc
Phone: 763-526-2332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place