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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

August 4, 2008

Start Date ^†

January 2005

Current Primary Outcome Measures ^†

Prediction by OptiVol of HF-related hospitalizations with signs and/or symptoms of pulmonary congestion. [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00400985 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Worsening HF status with signs and/or symptoms of pulmonary congestion: OptiVol benefits [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Heart Failure, Congestive

Intervention ^†

Device: Insync Sentry device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

500

Estimated Completion Date

December 2010

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Monique Marijianowski, Dr.	(+31-43) 3566657	monique.marijianowski@medtronic.com
Contact: Kitty Kempen, Dr.	(+31-43) 3566-638	kitty.kempen@medtronic.com

Location Countries ^†

Belgium, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400985

Responsible Party

Sponsor: Monique Marijianowski, Dr, Medtronic, Bakken Research Center

Secondary IDs ^††

Study Sponsor ^†

Medtronic Bakken Research Center

Collaborators ^††

Medtronic

Investigators ^†

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

Information Provided By

Medtronic Bakken Research Center

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.