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

NCT00400985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2025-07-02

Study results available
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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.

Conditions

  • Heart Failure, Congestive

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Viviane Conraads, Professor · UZA, Antwerpen, Belgium

  • Martin Cowie, Professor · Royal Brompton Hospital, London, UK

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Belgium
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400985 on ClinicalTrials.gov