Reveal LINQ Usability Study

See protocol page 13 , 14

Medtronic*s current Reveal DX/XT Insertable Cardiac Monitor (ICM) offers unique
diagnostic monitoring insights to cardiologists managing their patients at risk
of syncope or arrhythmias. The Reveal DX/XT ICM can aid physicians in
determining whether symptoms such as fainting, dizziness, palpitations, and
unexplained seizure-like episodes have cardiovascular cause and may help to
uncover asymptomatic arrhythmias.

Reveal LINQ is a new ICM system that records subcutaneous ECG.

The Reveal LINQTM has many of the same features as the currently marketed
Reveal XT. The primary improvements include a reduced device size; wireless
telemetry; the addition of the pwave algorithm for AF detection and a new
format for data accessibility/review.

See protocol page 23

This study is designed to assess the usability and functionality of the Reveal
LINQ system. Data from the first 30 patients, with 30 days of follow-up, will
be used to assess sensing performance and wireless capabilities of the Reveal
LINQsystem (Phase I). The data from the remaining 120 subjects will also assess
performance of the AF algorithm (Phase II).

See protocol page 22

The Reveal LINQ study is a prospective, non-blinded, non-randomized,
multi-center clinical trial.

Subjects will have required follow up visits at baseline/ implant, 1 month, 6
months and 12 months. Subjects will transmit device data via manual
interrogation on a weekly basis during the first month in addition to a 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. Following the 1 month follow-up visits,
subjects will transmit device data via manual interrogation on a monthly basis
until study exit. All subjects (Phase I and Phase II) will complete the 12
month follow-up period and be exited at their 12 month follow-up visit.

It is required for pre-ablation subjects to complete the initial 30 day
monitoring period prior to the ablation procedure.

The following interventions are additional for all subjects in the;

- Short-patient assessment at implantation, 1, 6, and 12 months
- 48h Holter at 1 month visit
- Xray at implantation and 1 month
- Weekly manual CarleLink transmission till 1 month follow-up, and a monthly
transmission till 12 month follow-up (is end of study)

See protocol page 54-56

Risk associated with a device implant and followed procedures.
Possible additional risks for participating in this study include the following:
* It can happen that for example by loss of contact no signal of noise is
detected by the Reveal LINQ. The Reveal LINQ would indicat that there is a Fast
VT or an asystole which in reality is not the case.
* The electrodes used with the DR220 Holter recorder might cause mild skin
discomfort or irritation
* Study sponsor may decide to stop the study before getting approval of the
investigational product. This may limit those centers having the supporting
investigational software for future follow-up needs.
* There may be other discomforts and risks related to the Reveal LINQTM device
and/or this study that are not foreseen at this time.
* There may be unforeseen risk to pregnant women or to the embryo or fetus.

Subject may benefit from the smaller size of the Reveal LINQ compared to
previous ICM models. Besides that the Reveal LINQ Usability Study may offer no
direct personal benefit to individual subjects. Subjects may benefit from
continuous ECG monitoring with the Reveal ICM, as this monitoring could result
in diagnosis of AF (or other arrhythmias) and comprehensive evaluation of
symptoms on an earlier and more conclusive basis than what would be possible
without an implantable monitor. Subjects may also benefit from being evaluated
more frequently in the office according to the study visit schedule.