Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

• ClinicalTrials.gov Identifier: NCT01965899
• Recruitment Status: Completed
• First Posted: October 18, 2013
• Results First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Study Description

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

Condition or disease	Intervention/treatment	Phase
Syncope; Recurrent Symptomatic Atrial Fibrillation	Device: Insertable Cardiac Monitor Implant	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Reveal LINQ Usability Study
• Study Start Date: September 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm

Intervention/treatment

Experimental: Insertable Cardiac Monitor Implant

Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Success of Wireless Transmissions [ Time Frame: 30 days ]
   To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
2. R-wave Amplitude [ Time Frame: 30 days ]
   To characterize the signal quality of the R-wave amplitude at implant and one month.
3. R-wave Amplitudes Greater Than or Equal to 200 μV [ Time Frame: 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 :

1. Accuracy of Reveal LINQ Device Detected Atrial Fibrillation [ Time Frame: 4 months ]
   To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.
2. Safety Endpoint [ Time Frame: 12 months ]
   To characterize the system-related and procedure-related adverse events.
3. Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor [ Time Frame: 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.
4. Survey of the Implanting Physicians [ Time Frame: 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?".
5. Survey of the Patient Experience Over Time [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Australia, Queensland

The Prince Charles Hospital

Brisbane, Queensland, Australia, 4032

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Royal Melbourne Hospital

Melbourne, Victoria, Australia, 3050

Austria

Allgemein öffentliches Krankenhaus der Elisabethinen Linz

Linz, Austria

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Belgium

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

CHU UCL Mont-Godinne - Dinant

Yvoir, Belgium

Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, Netherlands

Diakonessenhuis Locatie Utrecht

Utrecht, Netherlands

Isala Klinieken - Locatie Weezenlanden

Zwolle, Netherlands

Russian Federation

Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies

Novosibirsk, Russian Federation

Slovakia

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

Bratislava, Slovakia

United Kingdom

Eastbourne District General Hospital

Eastbourne, United Kingdom

James Cook University Hospital

Middlesbrough, United Kingdom

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

Investigators

• Principal Investigator: Helmut Pürerfellner, MD; Allgemein öffentliches Krankenhaus der Elisabethinen Linz
• Principal Investigator: Lukas Dekker, MD; Catharina Ziekenhuis

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pürerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT01965899
• Other Study ID Numbers: Reveal LINQ Usability Study
• First Posted: October 18, 2013
• Results First Posted: September 23, 2016
• Last Update Posted: September 23, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Syncope; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases