OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and CareLink Network (OptiLink-HF)
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|ClinicalTrials.gov Identifier: NCT00769457|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : May 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Access Arm||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1002 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network)|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Arm with activated OptiVol / Carelink-system, event-triggered physician alert and physician access to Cardiac Compass data
Device: Access Arm
Active OptiVol-System with CareAlert via CareLink
No Intervention: 2
Arm with standard ICD - CRT-D therapy, no OptiVol and no Carelink
- All-cause of death or unplanned admission to hospital for cardiovascular reason from day of patient informed consent sign off [ Time Frame: 18 Months ]
- Number of HF-related hospitalization during follow-up, HF-related hospitalization, Sum of follow-up days minus days alive and out of the hospital, All cause mortality, Cardiovascular Mortality, [ Time Frame: 18 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769457
|Universitätsklinikum des Saarlandes|
|Homburg-Saar, Saarland, Germany, 66424|
|Principal Investigator:||Michael Boehm, Professor||Universitätsklinikum des Saarlandes, Homburg-Saar|
|Study Chair:||Johannes Brachmann, Professor||Klinikum Coburg GmbH|