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Sponsors and Collaborators: |
Medtronic Bakken Research Center Medtronic |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00170313 |
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.
Condition | Intervention | Phase |
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Heart Failure Sudden Cardiac Death Atrial Fibrillation |
Device: Conducted AF-Response Algorithm |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Conducted AF-Response Study (Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation Treated With InSync III Marquis) |
Estimated Enrollment: | 100 |
Study Start Date: | December 2003 |
Study Completion Date: | January 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Marien-Hospital Herne | |
Herne, Germany, 44625 | |
Medizinische Hochschule Hannover | |
Hannover, Germany, 30625 | |
Klinikum der Justus-Liebig-Universität | |
Gießen, Germany, 35385 | |
Universitätsklinikum Aachen | |
Aachen, Germany, 52066 | |
Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg | |
Siegburg, Germany, 53721 | |
Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH | |
Duisburg, Germany, 47137 | |
Berufsgenossenschaftliche Kliniken Bergmannsheil | |
Bochum, Germany, 44789 |
Principal Investigator: | Christian Perings, MD | Marien-Hospital Herne |
Study ID Numbers: | CEN_G_CA_6 |
Study First Received: | September 13, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00170313 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Heart Failure Primary Prevention of Sudden Cardiac Death Secondary Prevention of Sudden Cardiac Death |
Cardiac Desynchronization CRT-D Cardiac Dyssynchrony |
Death Heart Failure Heart Diseases Death, Sudden Neoplasm Metastasis |
Heart Arrest Atrial Fibrillation Death, Sudden, Cardiac Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |