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Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Primary Purpose

Syncope, Recurrent Symptomatic Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Insertable Cardiac Monitor Implant
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Prince Charles Hospital
  • Royal Adelaide Hospital
  • Royal Melbourne Hospital
  • Allgemein öffentliches Krankenhaus der Elisabethinen Linz
  • Allgemeines Krankenhaus der Stadt Linz
  • UZ Leuven - Campus Gasthuisberg
  • CHU UCL Mont-Godinne - Dinant
  • Catharina Ziekenhuis
  • Academisch Ziekenhuis Maastricht
  • St. Antonius Ziekenhuis - Locatie Nieuwegein
  • Diakonessenhuis Locatie Utrecht
  • Isala Klinieken - Locatie Weezenlanden
  • Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies
  • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
  • Eastbourne District General Hospital
  • James Cook University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insertable Cardiac Monitor Implant

Arm Description

Outcomes

Primary Outcome Measures

Success of Wireless Transmissions
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
R-wave Amplitude
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
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

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.
Safety Endpoint
To characterize the system-related and procedure-related adverse events.
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.
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?".
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.

Full Information

First Posted
October 16, 2013
Last Updated
August 2, 2016
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01965899
Brief Title
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
Official Title
Reveal LINQ Usability Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Recurrent Symptomatic Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insertable Cardiac Monitor Implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Insertable Cardiac Monitor Implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success of Wireless Transmissions
Description
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
Time Frame
30 days
Title
R-wave Amplitude
Description
To characterize the signal quality of the R-wave amplitude at implant and one month.
Time Frame
30 days
Title
R-wave Amplitudes Greater Than or Equal to 200 μV
Description
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
Secondary Outcome Measure Information:
Title
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
Description
To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.
Time Frame
4 months
Title
Safety Endpoint
Description
To characterize the system-related and procedure-related adverse events.
Time Frame
12 months
Title
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
Description
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
Title
Survey of the Implanting Physicians
Description
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
Title
Survey of the Patient Experience Over Time
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Pürerfellner, MD
Organizational Affiliation
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lukas Dekker, MD
Organizational Affiliation
Catharina Ziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
City
Linz
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
Country
Austria
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
CHU UCL Mont-Godinne - Dinant
City
Yvoir
Country
Belgium
Facility Name
Catharina Ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis - Locatie Nieuwegein
City
Nieuwegein
Country
Netherlands
Facility Name
Diakonessenhuis Locatie Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Isala Klinieken - Locatie Weezenlanden
City
Zwolle
Country
Netherlands
Facility Name
Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies
City
Novosibirsk
Country
Russian Federation
Facility Name
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
City
Bratislava
Country
Slovakia
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25728756
Citation
Purerfellner 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.
Results Reference
derived

Learn more about this trial

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

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