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OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and CareLink Network

NCT00769457 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1002

Last updated 2025-07-03

No results posted yet for this study

Summary

Patients suffering from heart failure and a markedly reduced pumping capacity and sometimes desynchronization of the lower chambers of the heart have a higher risk of suffering sudden cardiac death.

These patients can be treated with an Implantable Cardiac Defibrillator that terminates dangerously fast heartbeats and in case of asynchronous pumping of the heart can also re-synchronize the lower chambers of the heart (ICD- or CRT-D-system). Patients that moreover suffered from a worsening of their cardiac status (cardiac decompensation) and had to be hospitalized for this reason have a higher risc to have following decompensations. New technology, incorporated into modern Medtronic ICD- and CRT-D-Systems, that measures the amount of water in the lungs is able to warn before such a dangerous worsening occurs. If coupled with modern data transmitting technology (CareLink), automatic information in case of a worsening of the cardiac status can be sent to caregivers, who in turn can react timely in order to prevent a worsening an subsequent hospitalization.

The study examines to which extent this new technology prevents potentially adverse cardiac situations and / or hospitalizations and has an influence of the duration of patient´s lives.

Conditions

Interventions

DEVICE

Access Arm

Active OptiVol-System with CareAlert via CareLink

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Michael Boehm, Professor · Universitätsklinikum des Saarlandes, Homburg-Saar

  • Johannes Brachmann, Professor · Klinikum Coburg GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Germany

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Diseases
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 NCT00769457 on ClinicalTrials.gov