Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reveal LINQ Usability Study

Conditions
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Syncope, Recurrent Symptomatic Atrial Fibrillation

Intervention / Treatment
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* Device: Insertable Cardiac Monitor Implant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insertable Cardiac Monitor Implant<br> | Device: Insertable Cardiac Monitor Implant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Wireless Transmissions | To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant. | 30 days | 
| R-wave Amplitude | To characterize the signal quality of the R-wave amplitude at implant and one month. | 30 days | 
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 
| Safety Endpoint | To characterize the system-related and procedure-related adverse events. | 12 months | 
| 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. | 48 hours | 
| 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?. | Day of implant | 
| 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. | 12 months |