OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and CareLink Network (OptiLink-HF)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network)|
- All-cause of death or unplanned admission to hospital for cardiovascular reason from day of patient informed consent sign off [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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
The objective of the study is to establish whether the use of event-triggered HF-disease management through Medtronic's OptiVol® fluid status monitoring with an automatically generated wireless CareAlert® notification of the clinician via the Medtronic CareLink® Network can reduce cardiovascular related hospitalizations and the number of deaths in a subject population with HF and ICD / CRT-D treatment as compared to standard clinical assessment. As a measure for the reduction of hospitalizations and deaths the rate of all cause deaths or cardiovascular related hospitalizations will be determined.
|Contact: Michael Boehm, Professor||0049 firstname.lastname@example.org|
|Contact: Gunnar Klein, Professor||0049 email@example.com|
|Universitätsklinikum des Saarlandes||Recruiting|
|Homburg-Saar, Saarland, Germany, 66424|
|Contact: Michael Boehm, Professor +49 (0)6841-16-23372 firstname.lastname@example.org|
|Contact: Gunnar Klein, MD +49 (0)511-364030 email@example.com|
|Principal Investigator:||Michael Boehm, Professor||Universitätsklinikum des Saarlandes, Homburg-Saar|
|Study Chair:||Johannes Brachmann, Professor||Klinikum Coburg GmbH|