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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00480077 |
The DOT-HF trial is an international, prospective, multi-center, randomized, controlled trial.
Condition | Intervention | Phase |
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Heart Failure |
Device: Programming (CRT-D, CRT, ICD OptiVol® and Cardiac Compass® ) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Diagnostic Outcome Trial in Heart Failure |
Estimated Enrollment: | 2300 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol® Alert and/or SentryCheck™ Monitor/PatientLook™ Indicator and evaluation using OptiVol® Fluid Status Monitoring with Cardiac Compass. OptiVol® Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products (CRT, CRT-D and ICD devices)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Medtronic Bakken Research Center | |
Maastricht, Netherlands, 6229 GW |
Study Chair: | Prof. D.J. van Veldhuisen, MD | Groningen University Hospital, The Netherlands |
Study Chair: | Prof. Dr. med. M. Borggrefe | Ruprecht-Karls-Universität Heidelberg, Germany |
Principal Investigator: | Prof. Dr. V. Conraads | Universitair Ziekenhuis Antwerpen, Belgium |
Principal Investigator: | Prof. C.M. Yu | Prince of Wales Hospital, Hong Kong |
Principal Investigator: | Dr. F. Braunschweig | Karolinska University Hospital |
Principal Investigator: | Prof. Dr. J. Kautzner | IKEM- Klinika Kardiologie, Czech Republic |
Principal Investigator: | Prof. Dr. G. Jondeau | Hôpital Bichat Claude Bernard, France |
Principal Investigator: | Prof. Dr. M.R. Cowie | National Heart & Lung Institute, United Kingdom |
Principal Investigator: | Dr. R. Muñoz-Aguilera | Hospital General Universitario Gregorio Marañon, Spain |
Principal Investigator: | Prof. I. Ford | Robertson Center for Biostatistics, Scotland |
Study ID Numbers: | 20061016-V2 |
Study First Received: | May 29, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00480077 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |