Heart Failure
Conditions
Brief summary
The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
Detailed description
The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up. The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.
Interventions
DEVICEReveal LINQ™ Insertable Cardiac Monitor (ICM)
Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 and CareLink transmissions * Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment * Patient had a HF event (HF event defined as meeting any one of the following three criteria): 1. Admission with primary diagnosis of HF within the last 6 months, OR 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months: * Admission with secondary/tertiary diagnosis of HF * Emergency Department * Ambulance * Observation Unit * Urgent Care * HF/Cardiology Clinic * Patient's Home, OR 3. Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP\> 200 pg/ml or NTpro-BNP \> 400 pg/ml OR If EF \<50%, then BNP\> 400 pg/ml or NTpro-BNP \> 800 pg/ml
Exclusion criteria
* Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment) * Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager * Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve * Patient has existing IPG, ICD, CRT-D or CRT-P device * Patient has severe renal impairment (eGFR \<25mL/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event | 30 days post-Reveal LINQ insertion to 3 years post-implant | A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: 1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and 2. A possible second ADHF event must be greater than 90 days after the first ADHF event Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event. |
| Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events | > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant | A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event. Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reveal LINQ Cohort Subjects inserted with a Reveal LINQ implantable cardiac monitor | 104 |
| Enrolled But Not Inserted Group Subjects who were enrolled in the Reveal LINQ HF study, but did not undergo an insertion attempt of a Reveal LINQ device, but had a Baseline Form Completed. | 7 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 0 |
| Overall Study | Lost to Follow-up | 7 | 0 |
| Overall Study | Physician Decision | 10 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Enrolled But Not Inserted Group | Total | Reveal LINQ Cohort |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 14.7 | 66.9 years STANDARD_DEVIATION 11.1 | 66.8 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 108 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 18 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 92 Participants | 86 Participants |
| Region of Enrollment United States | 7 Participants | 111 Participants | 104 Participants |
| Sex: Female, Male Female | 2 Participants | 69 Participants | 67 Participants |
| Sex: Female, Male Male | 5 Participants | 42 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 104 | 0 / 8 |
| other Total, other adverse events | 0 / 104 | 0 / 0 |
| serious Total, serious adverse events | 0 / 104 | 0 / 0 |
Outcome results
Primary
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event. Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Time frame: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant
Population: Subjects who experienced an ADHF event at least 30 days post-Reveal LINQ insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reveal LINQ Cohort | Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events | 12 participants |
Primary
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: 1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and 2. A possible second ADHF event must be greater than 90 days after the first ADHF event Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Time frame: 30 days post-Reveal LINQ insertion to 3 years post-implant
Population: Subjects inserted with a Reveal LINQ device
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reveal LINQ Cohort | Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event | 36 participants |