Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Not Applicable

Completed

Conditions: Syncope
Recurrent Symptomatic Atrial Fibrillation

Interventions: Device: Insertable Cardiac Monitor Implant

Registration Number: NCT01965899

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insertable Cardiac Monitor Implant	Insertable Cardiac Monitor Implant	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (16): The Prince Charles Hospital
🇦🇺
Brisbane, Queensland, Australia
UZ Leuven - Campus Gasthuisberg
🇧🇪
Leuven, Belgium
CHU UCL Mont-Godinne - Dinant
🇧🇪
Yvoir, Belgium
Academisch Ziekenhuis Maastricht
🇳🇱
Maastricht, Netherlands
Eastbourne District General Hospital
🇬🇧
Eastbourne, United Kingdom
James Cook University Hospital
🇬🇧
Middlesbrough, United Kingdom
Allgemeines Krankenhaus der Stadt Linz
🇦🇹
Linz, Austria
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
🇦🇹
Linz, Austria
Royal Melbourne Hospital
🇦🇺
Melbourne, Victoria, Australia
Catharina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
St. Antonius Ziekenhuis - Locatie Nieuwegein
🇳🇱
Nieuwegein, Netherlands
Diakonessenhuis Locatie Utrecht
🇳🇱
Utrecht, Netherlands
Isala Klinieken - Locatie Weezenlanden
🇳🇱
Zwolle, Netherlands
Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies
🇷🇺
Novosibirsk, Russian Federation
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
🇸🇰
Bratislava, Slovakia
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia