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Sponsors and Collaborators: |
Medtronic Bakken Research Center Medtronic |
Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00170261 |
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.
Condition | Intervention | Phase |
Syncope |
Device: Use of an Implantable Loop Recorder |
Phase IV |
MedlinePlus related topics: | Fainting |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Early Loop-Recorder in Suspected Arrhythmogenic Syncope |
Estimated Enrollment: | 100 |
Study Start Date: | April 2002 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Vivantes Klinikum am Urban | |||||
Berlin, Germany, 10967 | |||||
Humbold Klinikum | |||||
Berlin, Germany, 13509 | |||||
Universitätsklinikum Hamburg Eppendorf | |||||
Hamburg, Germany, 20251 |
Medtronic Bakken Research Center |
Medtronic |
Principal Investigator: | H.-C- Ehlers, MD | Vivantes Klinikum am Urban |
Study ID Numbers: | CEN_G_CA_4 |
First Received: | September 12, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00170261 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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