Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE)

Chronic heart failure (HF) has a worldwide rate of incidence and prevalence of
almost epidemic proportions. In the United States, 5.7 million patients have HF
with about 670,000 new patients diagnosed every year. It is estimated that over
50 million Medicare beneficiaries will have HF by 2020 2. Over 1 million annual
hospitalizations result from HF, accounting for about 70% of the total
HF-related economic burden estimated at $56 billion per year. In 51 countries
represented by the European Society of Cardiology there are at least 15 million
HF patients that account for about 2% of the expenditure on health, mostly due
to the cost of hospital admissions. Patient monitoring and management aimed at
preventing hospitalizations could not only benefit health care economics but
also improve patient quality of life and avoid HF hospitalizations correlated
to disease severity or progression.
The pathophysiological mechanisms that lead to acute decompensated HF and its
associated hospitalizations are complex - however, the large majority of HF
hospitalizations occur from symptoms related to volume overload. Traditional
methods of physical examination have limited sensitivity and specificity, and
require frequent patient visits. Sensors integral to Boston Scientific*s CRV
devices and the remote monitoring LATITUDE infrastructure provide a unique
platform to continuously monitor patients for sub-clinical changes in HF status
and alert the clinician to an impending worsening HF event. The feasibility of
monitoring HF status using implanted device sensors has been shown, and studies
are ongoing to determine efficacy for preventing hospitalizations. The
detection performance of some individual sensor algorithms are reported to
range from 50% to 70% sensitivity with 1.5 to 2.5 false positives per
patient-year, while providing an advance warning of about 2 weeks. The primary
goal of the MultiSENSE study is to determine if integrating information from
judiciously selected HF sensors in Boston Scientific*s CRT-D devices can
improve detection performance.

The purpose of the MultiSENSE study is to collect chronic ambulatory data
simultaneously from multiple sensors in CRT-D devices in order to develop
algorithms for the early detection of worsening HF.
The primary objectives of this study are to determine how ambulatory sensor
measurements change with worsening HF, and to develop multisensor detection
algorithms.
Additional data will be collected to compare sensor measurements against
reference measurements when the subject is hospitalized for HF. Data from this
study may also be used for determining prospective endpoints and sample sizes
for future studies.
There are no formal statistical primary or secondary endpoints defined for this
study. Therefore, no formal tests of hypothesis will be conducted.

The MultiSENSE study is a multi-center, international, prospective,
non-randomized, feasibility, significant risk IDE study.Subjects included in
the study will be followed for up to 15 months. Subjects will have their
devices converted to an SRD-1 no earlier than 30 days post-implant and no later
than 44 days post-enrollment. After conversion, subjects will be followed for a
maximum of 12 months. Following device re-conversion the subject will be
followed for an additional 30 to 44 days.
Once the subject*s COGNIS device is converted to a SRD-1, sensor data will be
continuously stored in device memory. Data stored in the SRD-1 will be
recovered from the implanted device using either subject follow-up visits to
the investigational center, or using remote LATITUDE downloads.
The duration of the MultiSENSE study is expected to be four (4) years.

The MultiSENSE study is a significant risk IDE study. Investigational software
will be downloaded into an implanted COGNIS device to convert it to a Sensor
Research Device (SRD-1). Following conversion, the SRD-1 PG will provide study
data collection features while maintaining all essential therapy and diagnostic
features of the COGNIS. At the completion of the subject*s participation in the
study, the SRD-1 will be restored to a COGNIS device.
The main risk is that the subject should seek device related care (routine or
emergency) at an investigating center and that the device longevity will be
reduced by up to 6 months. The subject may receive a benefit from an increased
follow-up schedule. Participation in this study is intended to provide the
necessary data to develop future algorithms for detection of worsening HF
events.