Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Reveal LINQ Usability Study

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.

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)