Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-08-31

Brief Summary

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The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.

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Detailed Description

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The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart Failure related events associated with signs and symptoms of pulmonary congestion and in the subject HF therapy management.

The OptiVol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. An Alert warns the patient whenever a programmable threshold has been reached.

The study is divided into three phases.

The first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related hospitalizations with signs and/or symptoms of pulmonary congestion.

In the second phase of the study, the Alert is turned ON and the positive predictive value of the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated.

The third phase of the study allows for remote subject therapy management using the OptiVol Patient Alert. The patient management strategy is then based on the experience gained in the second study phase Physician actions taken in the occurrence of a Patient Alert will be summarized.

Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Study Groups

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Implantable Device diagnostics

All enrolled subjects were implanted with a device. Audible Device diagnostics turned on or off

Group Type OTHER

Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.

Intervention Type DEVICE

SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.

Interventions

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Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.

SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Successfully implanted InSync Sentry device (\< 34 days post implant or pocket revision)in the pectoral region;
* At least one HF-related hospitalization that required administration of IV medication (inotropes, nitrates, diuretics) within the last 12 months
* The Subject has a market released, transvenous, high voltage Right Ventricular lead
* The Subject is able to detect a Patient Alert signal

* Inclusion of patients with Concerto/Virtuoso devices.
* At least one HF-related hospitalization that required administration of IV (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months

Exclusion Criteria

* \<18 years of age (or under a minimum age required by local law)
* Moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
* Post heart transplant or awaiting heart transplantation
* Primary pulmonary hypertension
* Renal insufficiency requiring dialysis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No