Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure - Full Text View

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00400985

Purpose

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 HF-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.

Condition	Intervention
Heart Failure, Congestive	Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Prediction by OptiVol of HF-related hospitalizations with signs and/or symptoms of pulmonary congestion. [ Time Frame: 34 days post device implant to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the clinical utility of the OptiVol feature [ Time Frame: 34 days post device implant to 2 years ] [ Designated as safety issue: No ]

Enrollment:	501
Study Start Date:	January 2005
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

SENSE-HF is not a randomized trial. Study divided in 3 phases among which the first is blinded to the diagnostic data.

Detailed Description:

The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of HF-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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 RV lead
The Subject is able to detect a Patient Alert signal

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

Amendment to the inclusion criteria (Jul 06):

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400985

Locations

Belgium
UZA
Antwerpen, Belgium
United Kingdom
Royal Brompton
London, United Kingdom

Sponsors and Collaborators

Medtronic Bakken Research Center

Medtronic

Investigators

Principal Investigator:	Viviane Conraads, Professor	UZA, Antwerpen, Belgium
Principal Investigator:	Martin Cowie, Professor	Royal Brompton Hospital, London, UK

More Information

Additional Information:

Public website This link exits the ClinicalTrials.gov site

Publications:

Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. Epub 2005 Aug 1.

Responsible Party:	Medtronic, Bakken Research Center ( Sponsor: Sandra Jacobs Ph.D )
Study ID Numbers:	SENSE-HF, V.1, Dec.8, 2004
Study First Received:	September 13, 2005
Last Updated:	June 11, 2009
ClinicalTrials.gov Identifier:	NCT00400985 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Bakken Research Center:

Heart Failure, Congestive
Diagnostic
Ambulatory Monitoring
Intrathoracic Impedance

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 03, 2009