Atrial Fibrillation, Heart Failure
Conditions
Brief summary
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.
Interventions
DEVICEReveal XT® Insertable Cardiac Monitor
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).
OTHERHeart 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 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years of age or older * Patient (or patient's legally authorized representative) is willing and able to provide written informed consent * Patient is willing and able to comply with the protocol, including follow-up visits * Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations) * Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor * Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home * Willing and able to transmit data via CareLink
Exclusion criteria
* Patient is pregnant * Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures * Endstage (Stage D or New York Heart Association class IV) heart failure * Asymptomatic (Stage B or New York Heart Association class I) heart failure * Severe aortic stenosis or insufficiency * Existing insertable cardiac monitor implanted for more than 1 year * Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device * Severe renal impairment (estimated glomerular filtration rate \<25mL/min) * Myocardial infarction within prior 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of HFRS Status With Actions/Testing | 6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm) | 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. |
| Clinical Status Measures | 0 to 18 months post-implant | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 10 |
| Not Randomized Subjects who were not randomized | 7 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Device explanted with/without re-implant | 3 | 2 | 0 | 2 |
| Overall Study | Not meeting eligibility criteria | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Risk Status Guided | Control Arm | Not Randomized |
|---|---|---|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 12 | 66.2 years STANDARD_DEVIATION 15.3 | 74.9 years STANDARD_DEVIATION 7.6 | 70.3 years STANDARD_DEVIATION 9.7 |
| Heart Failure Stage Not available | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Heart Failure Stage Stage C | 20 Participants | 9 Participants | 6 Participants | 5 Participants |
| LVEF | 57.3 percentage STANDARD_DEVIATION 10.2 | 60.2 percentage STANDARD_DEVIATION 10.7 | 60.0 percentage STANDARD_DEVIATION 4.1 | 50.6 percentage STANDARD_DEVIATION 11.6 |
| New York Heart Assocation (NYHA) Functional Classification NYHA Class II | 14 number | 6 number | 5 number | 3 number |
| New York Heart Assocation (NYHA) Functional Classification NYHA Class III | 10 number | 4 number | 2 number | 4 number |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 10 Participants | 6 Participants | 7 Participants |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 10 |
| other Total, other adverse events | 6 / 7 | 7 / 10 |
| serious Total, serious adverse events | 6 / 7 | 5 / 10 |
Outcome results
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.
Time frame: 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | High/Very High Score & HF Event(s) | 5 participants |
| Control Arm | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | High/Very High Score, No HF Event(s) | 2 participants |
| Control Arm | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | HF Event(s), No High/Very High Score | 0 participants |
| Control Arm | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | No High/Very High Score or HF Event(s) | 0 participants |
| Risk Status Guided | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | No High/Very High Score or HF Event(s) | 1 participants |
| Risk Status Guided | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | High/Very High Score & HF Event(s) | 2 participants |
| Risk Status Guided | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | HF Event(s), No High/Very High Score | 0 participants |
| Risk Status Guided | Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events | High/Very High Score, No HF Event(s) | 7 participants |
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.
Time frame: 0 to 18 months post-implant
Population: Subjects randomized to the Risk Status Guided Arm
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control Arm | Clinical Status Measures | High/Very High HFRS Score During Guided Period | 7 Outcome of Patients During Guided Period |
| Control Arm | Clinical Status Measures | 6 Minute Hall Walk Improved During Guided Period | 3 Outcome of Patients During Guided Period |
| Control Arm | Clinical Status Measures | Quality of Life Improvement During Guided Period | 5 Outcome of Patients During Guided Period |
| Control Arm | Clinical Status Measures | Improved NYHA During Guided Period | 4 Outcome of Patients During Guided Period |
| Control Arm | Clinical Status Measures | HF Event During Guided Period | 6 Outcome of Patients During Guided Period |
| Risk Status Guided | Clinical Status Measures | Improved NYHA During Guided Period | 0 Outcome of Patients During Guided Period |
| Risk Status Guided | Clinical Status Measures | HF Event During Guided Period | 1 Outcome of Patients During Guided Period |
| Risk Status Guided | Clinical Status Measures | High/Very High HFRS Score During Guided Period | 1 Outcome of Patients During Guided Period |
| Risk Status Guided | Clinical Status Measures | Quality of Life Improvement During Guided Period | 0 Outcome of Patients During Guided Period |
| Risk Status Guided | Clinical Status Measures | 6 Minute Hall Walk Improved During Guided Period | 0 Outcome of Patients During Guided Period |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Arm | Correlation of HFRS Status With Actions/Testing | Significant Weight Gain Reported | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | High Blood Pressure | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | HF Symptoms Reported | 1 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Medications Adjusted due to HFRS Score | 1 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Rate Control Meds Adjusted due to HFRS Score | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Blood Pressure Meds Adjusted due to HFRS Score | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Diuretics Adjusted due to HFRS Score | 1 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Directed to Clinic | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Directed to Emergency Department | 0 Visits with high/very high score |
| Control Arm | Correlation of HFRS Status With Actions/Testing | Directed to Hospital | 0 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Directed to Clinic | 9 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Significant Weight Gain Reported | 9 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Blood Pressure Meds Adjusted due to HFRS Score | 4 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | High Blood Pressure | 5 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Directed to Hospital | 0 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | HF Symptoms Reported | 46 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Diuretics Adjusted due to HFRS Score | 15 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Medications Adjusted due to HFRS Score | 18 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Directed to Emergency Department | 0 Visits with high/very high score |
| Risk Status Guided | Correlation of HFRS Status With Actions/Testing | Rate Control Meds Adjusted due to HFRS Score | 1 Visits with high/very high score |