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Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure (SENSE-HF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00400985
First received: September 13, 2005
Last updated: April 6, 2010
Last verified: April 2010
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.
    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:

Responsible Party: Sponsor: Sandra Jacobs Ph.D, Medtronic, Bakken Research Center
ClinicalTrials.gov Identifier: NCT00400985     History of Changes
Other Study ID Numbers: SENSE-HF, V.1, Dec.8, 2004
Study First Received: September 13, 2005
Last Updated: April 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Bakken Research Center:
Heart Failure, Congestive
Diagnostic
Ambulatory Monitoring
Intrathoracic Impedance

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013