Recurrent Symptomatic Atrial Fibrillation, Syncope
Conditions
Brief summary
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
Detailed description
The Reveal LINQ Usability Study is a prospective, non-blinded, non-randomized, multi-center clinical trial. Subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the MyCareLink® home monitor. All subjects will be requested to wear an external Holter for 48 hours at approximately 4 weeks post-insertion. Follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. Subjects will be exited at their 12 month follow-up visit. The overall study will be conducted in 2 phases which differ primarily on inclusion criteria: Phase I subjects (initial 30 subjects) will have any indication for an ICM, Phase II subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (AF) pre-ablation patients. The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission.
Interventions
DEVICEInsertable Cardiac Monitor Implant
The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Subject is willing to sign and date the consent form. * Subject is indicated for a Reveal device within the existing market approved indications * Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device * Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate\* \*Note: Atrial fibrillation must be documented in the subject's medical history. * Subject has a life expectancy of 18 months or more. * Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network) * Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must: * have a negative pregnancy test at enrollment. * not be breastfeeding. * either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
Exclusion criteria
* Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT, etc). * Subject is unwilling or unable to comply with the study procedures * Subject is legally incapacitated and unable to provide written informed consent. * Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis) * Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager. * Local law prohibits participation (e.g., minor status as specified by local law)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Wireless Transmissions | 30 days | To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant. |
| R-wave Amplitude | 30 days | To characterize the signal quality of the R-wave amplitude at implant and one month. |
| R-wave Amplitudes Greater Than or Equal to 200 μV | 30 days | The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survey of the Implanting Physicians | Day of implant | To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?. |
| Accuracy of Reveal LINQ Device Detected Atrial Fibrillation | 4 months | To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported. |
| Survey of the Patient Experience Over Time | 12 months | To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit. |
| Safety Endpoint | 12 months | To characterize the system-related and procedure-related adverse events. |
| Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | 48 hours | To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive. |
Countries
Australia, Austria, Belgium, Netherlands, Russia, Slovakia, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insertable Cardiac Monitor Implant Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained. | 151 |
| Total | 151 |
Baseline characteristics
| Characteristic | Insertable Cardiac Monitor Implant |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Australia | 33 participants |
| Region of Enrollment Austria | 28 participants |
| Region of Enrollment Belgium | 10 participants |
| Region of Enrollment Netherlands | 40 participants |
| Region of Enrollment Russian Federation | 7 participants |
| Region of Enrollment Slovakia | 25 participants |
| Region of Enrollment United Kingdom | 8 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 151 |
| serious Total, serious adverse events | 31 / 151 |
Outcome results
Primary
R-wave Amplitude
To characterize the signal quality of the R-wave amplitude at implant and one month.
Time frame: 30 days
Population: For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insertable Cardiac Monitor Implant | R-wave Amplitude | R-wave at implant (n=151) | 543.5 μV | Standard Deviation 294.8 |
| Insertable Cardiac Monitor Implant | R-wave Amplitude | R-wave at one month follow-up (n=150) | 599.4 μV | Standard Deviation 314.2 |
Primary
R-wave Amplitudes Greater Than or Equal to 200 μV
The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.
Time frame: 30 days
Population: For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | R-wave Amplitudes Greater Than or Equal to 200 μV | Implant | 97.3 Percentage of subjects |
| Insertable Cardiac Monitor Implant | R-wave Amplitudes Greater Than or Equal to 200 μV | 1 Month | 96.6 Percentage of subjects |
Primary
Success of Wireless Transmissions
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
Time frame: 30 days
Population: All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insertable Cardiac Monitor Implant | Success of Wireless Transmissions | 73.1 percentage of successful transmissions |
Secondary
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.
Time frame: 48 hours
Population: A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | Sensitivity | 97.4 Percentage of patients |
| Insertable Cardiac Monitor Implant | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | Specificity | 97.0 Percentage of patients |
| Insertable Cardiac Monitor Implant | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | Positive predictive value | 92.5 Percentage of patients |
| Insertable Cardiac Monitor Implant | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | Negative predictive value | 99.0 Percentage of patients |
| Insertable Cardiac Monitor Implant | Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor | Accuracy | 97.1 Percentage of patients |
Secondary
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.
Time frame: 4 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Accuracy of Reveal LINQ Device Detected Atrial Fibrillation | True positive | 4461 Episodes |
| Insertable Cardiac Monitor Implant | Accuracy of Reveal LINQ Device Detected Atrial Fibrillation | False positive | 843 Episodes |
Secondary
Safety Endpoint
To characterize the system-related and procedure-related adverse events.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Safety Endpoint | Procedure related | 9 Number of events |
| Insertable Cardiac Monitor Implant | Safety Endpoint | System related | 45 Number of events |
| Insertable Cardiac Monitor Implant | Safety Endpoint | Procedure related (Serious events) | 1 Number of events |
| Insertable Cardiac Monitor Implant | Safety Endpoint | System related (Serious events) | 1 Number of events |
Secondary
Survey of the Implanting Physicians
To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?.
Time frame: Day of implant
Population: There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question Overall, how would you rate the ease of entire implant procedure?.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Survey of the Implanting Physicians | Very Easy, No Changes Needed | 54.4 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Implanting Physicians | Easy, but Needs Small Improvement | 38.9 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Implanting Physicians | Needs Some Improvement | 5.4 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Implanting Physicians | Needs Significant Improvement | 1.3 Percentage of surveys |
Secondary
Survey of the Patient Experience Over Time
To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit.
Time frame: 12 months
Population: There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device was answered 434 times.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insertable Cardiac Monitor Implant | Survey of the Patient Experience Over Time | Very satisfied | 66.6 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Patient Experience Over Time | Satisified | 30.2 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Patient Experience Over Time | Needs Some Improvement | 2.8 Percentage of surveys |
| Insertable Cardiac Monitor Implant | Survey of the Patient Experience Over Time | Needs Significant Improvement | 0.5 Percentage of surveys |