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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
151
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.
The Prince Charles Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
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
R-wave Amplitude
To characterize the signal quality of the R-wave amplitude at implant and one month.
Time frame: 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.
Time frame: 30 days
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
Safety Endpoint
To characterize the system-related and procedure-related adverse events.
Time frame: 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.
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Royal Melbourne Hospital
Melbourne, Victoria, Australia
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
CHU UCL Mont-Godinne - Dinant
Yvoir, Belgium
Catharina Ziekenhuis
Eindhoven, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
St. Antonius Ziekenhuis - Locatie Nieuwegein
Nieuwegein, Netherlands
...and 6 more locations
Time frame: 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?".
Time frame: 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.
Time frame: 12 months