NCT00400985

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Heart Failure 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 Heart Failure 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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.	SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2006-11-17
• Last updated: 2025-07-02
• Results posted: 2018-10-22

Locations

2 sites across 2 countries: Belgium, United Kingdom