Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure (SENSE-HF)
|ClinicalTrials.gov Identifier: NCT00400985|
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : April 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Device: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||501 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
- 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.
- 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 ]
- To assess the clinical utility of the OptiVol feature [ Time Frame: 34 days post device implant to 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400985
|London, United Kingdom|
|Principal Investigator:||Viviane Conraads, Professor||UZA, Antwerpen, Belgium|
|Principal Investigator:||Martin Cowie, Professor||Royal Brompton Hospital, London, UK|