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

September 13, 2005
April 6, 2010
January 2005
August 2009   (final data collection date for primary outcome measure)
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 ]
Prediction of HF-related hospitalizations with signs and/or symptoms of pulmonary congestion.
Complete list of historical versions of study NCT00400985 on ClinicalTrials.gov Archive Site
To assess the clinical utility of the OptiVol feature [ Time Frame: 34 days post device implant to 2 years ] [ Designated as safety issue: No ]
Worsening HF status with signs and/or symptoms of pulmonary congestion.
Not Provided
Not Provided
 
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Heart Failure, Congestive
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United Kingdom
 
NCT00400985
SENSE-HF, V.1, Dec.8, 2004
No
Sponsor: Sandra Jacobs Ph.D, Medtronic, Bakken Research Center
Medtronic Bakken Research Center
Medtronic
Principal Investigator: Viviane Conraads, Professor UZA, Antwerpen, Belgium
Principal Investigator: Martin Cowie, Professor Royal Brompton Hospital, London, UK
Medtronic Bakken Research Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP