Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Syncope Clinical Trial

Official title:

Reveal LINQ Usability Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01965899
• Other study ID #: Reveal LINQ Usability Study
• Status: Active, not recruiting
• Phase: N/A
• First received: October 16, 2013
• Last updated: March 9, 2015
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Office for Radiation ProtectionNetherlands: Medical Ethics Review Committee (METC)Netherlands: Dutch Health Care InspectorateRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrent Symptomatic Atrial Fibrillation
• Syncope

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Austria	Allgemein öffentliches Krankenhaus der Elisabethinen Linz	Linz
Austria	Allgemeines Krankenhaus der Stadt Linz	Linz
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Belgium	CHU UCL Mont-Godinne - Dinant	Yvoir
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
Russian Federation	Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies	Novosibirsk
Slovakia	Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)	Bratislava
United Kingdom	Eastbourne District General Hospital	Eastbourne
United Kingdom	James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Netherlands,  Russian Federation,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	R-wave amplitude	To characterize the signal quality of the R-wave amplitude at implant and one month.	30 days	No
Secondary	Accuracy of Reveal LINQ device detected atrial fibrillation	To assess atrial fibrillation detection by the Reveal LINQ ICM. True and false positives will be reported.	12 months	No
Secondary	Safety endpoint	To characterize the system-related and procedure-related adverse events.	12 months	Yes
Secondary	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, false positive rate, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard.	12 months	No
Secondary	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. Explant experience will also be captured when applicable.	Day of implant	No
Secondary	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.	12 months	No