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Sponsors and Collaborators: |
Medtronic Bakken Research Center Medtronic IKFE Institute for Clinical Research and Development |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00769457 |
Patients suffering from heart failure and a marketdly reduced pumping capacity and sometimes de-synchronization 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 CRTD-Systems, that measures the amout 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 invluence of the duration of patient´s lives.
Condition | Intervention | Phase |
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Heart Failure |
Device: Access Arm |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | OptiLink HF Study (Optimization of Heart Failure Management Using Medtronic OptiVol® Fluid Status Monitoring and Medtronic CareLink® Network) |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm with activated OptiVol / Carelink-system, event-triggered physician alert and physician access to Cardiac Compass data
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Device: Access Arm
Active OptiVol-System with Care-Alert via CareLink
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2: No Intervention
Arm with standard ICD - CRT-D therapy, no OptiVol and no Carelink
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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 allcause deaths or cardiovascular related hospitalizations will be determined.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subjects have a Medtronic Virtuoso™ ICD single- or dual-chamber or Concerto™ CRT-D or subsequently market released Medtronic device providing at least the same functionality) implanted, including device replacement. Subjects with CRT-D must fulfill CRT-indication as described in the ESC guidelines for cardiac pacing and cardiac resynchronization therapy 2007: EF ≤ 35% and NYHA III, and LVEDD> 55 mm, and QRS ≥ 120 ms, and optimized therapy
Exclusion Criteria:
Contact: Helmut Drexler, MD | 0049 051153260 ext 840 | drexler.helmut@mh-hannover.de |
Contact: Gunnar Klein, MD | 0049 051153260 ext 523 | klein.gunnar@mh-hannover.de |
Germany, Niedersachsen | |
Medizinische Hochschule Hannover | Recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
Contact: Helmut Drexler, MD 0049511532360 ext 840 drexler.helmut@mh-hannover.de | |
Contact: Gunnar Klein, MD 00495115326523 klein.gunnar@mh-hannover.de |
Principal Investigator: | Helmut Drexler, MD | Hannover Medical School |
Study Chair: | Johannes Brachmann, MD | Klinikum Coburg gGmbH |
Responsible Party: | Medizinische Hochschule Hannover ( Professor Dr. med. Helmut Drexler ) |
Study ID Numbers: | CEN_G_CA_8 |
Study First Received: | October 8, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00769457 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Heart Failure Heart Diseases |
Cardiovascular Diseases |