OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and Medtronic CareLink Network (OptiLink-HF)
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | October 8, 2008 | ||||||||
Last Updated Date | May 11, 2011 | ||||||||
Start Date ICMJE | September 2008 | ||||||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE |
All-cause of death or unplanned admission to hospital for cardiovascular reason from day 35 after implantation [ Time Frame: 18 Months ] [ Designated as safety issue: No ] | ||||||||
Change History | Complete list of historical versions of study NCT00769457 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | OptiLink HF Study: Optimization of Heart Failure Management Using Medtronic OptiVol Fluid Status Monitoring and Medtronic CareLink Network | ||||||||
Official Title ICMJE | OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network) | ||||||||
Brief 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. |
||||||||
Detailed Description | 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. |
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
||||||||
Condition ICMJE | Heart Failure | ||||||||
Intervention ICMJE | Device: Access Arm
Active OptiVol-System with CareAlert via CareLink
Other Names:
|
||||||||
Study Arm (s) |
|
||||||||
Publications * | Brachmann J, Böhm M, Rybak K, Klein G, Butter C, Klemm H, Schomburg R, Siebermair J, Israel C, Sinha AM, Drexler H; OptiLink HF Study Executive Board and Investigators. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink). Eur J Heart Fail. 2011 Jul;13(7):796-804. Epub 2011 May 8. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 1000 | ||||||||
Estimated Completion Date | October 2013 | ||||||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | Germany | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00769457 | ||||||||
Other Study ID Numbers ICMJE | CEN_G_CA_8 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Professor Dr. med. Michael Boehm, Universitätsklinikum des Saarlandes, Homburg-Saar | ||||||||
Study Sponsor ICMJE | Medtronic Bakken Research Center | ||||||||
Collaborators ICMJE |
|
||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | Medtronic Bakken Research Center | ||||||||
Verification Date | May 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |