CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 501 enrolled
Drug / intervention
Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00400985
NCT00400985N/ACompleted
CompareCT.gov

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

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Nov 17, 2006·Updated Jul 2, 2025

In Brief

A clinical study evaluating Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. for Heart Failure, Congestive. Completed, enrolled 501 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive
CountriesBelgium, United Kingdom
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2006
Enrollment StartJan 1, 2005
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.6 years ago

Interventions

Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool.device

SENSE-HF is non randomized trial. Study divided in 3 phases among which the first phase is blinded towards device diagnostic data.