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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: | NCT00157846 |
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have ventricular dysfunction (left ventricular ejection fraction [LVEF] < 35%). All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. The endpoint is functional performance measured by spiroergonometry.
Condition | Intervention | Phase |
---|---|---|
Heart Failure, Congestive |
Device: Upgrade of old device to CRT-device during exchange |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation |
Estimated Enrollment: | 100 |
Study Start Date: | October 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Implanted dual-chamber pacemaker or ICD system with replacement indication
Because of upgrade from pacemaker to ICD system
Exclusion Criteria:
Cardiac surgery less than 3 months
Germany | |
Berufsgenossenschaftliche Kliniken Bergmannsheil | |
Bochum, Germany, 44789 | |
Charite Campus Virchow-Klinikum | |
Berlin, Germany, 13353 | |
Klinikum Augsburg I. Medizinische Klinik | |
Augsburg, Germany, 86156 | |
Märkische Kliniken GmbH Klinikum Luedenscheid | |
Luedenscheid, Germany, 58515 | |
Krankenhaus Reinbek St. Adolf Stift | |
Reinbek b. Hamburg, Germany, 21465 | |
St.-Vincentius Klinken | |
Karlsruhe, Germany | |
Städtisches Kreiskrankenhaus | |
Friedrichshafen, Germany | |
Unfallkrankenhaus Benjamin Franklin | |
Berlin, Germany | |
Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg | |
Bernau, Germany | |
Georg-August-Universität Göttingen | |
Göttingen, Germany |
Principal Investigator: | Thomas Lawo, MD | Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum |
Study ID Numbers: | CEN_G_CA_1 |
Study First Received: | September 9, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00157846 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Heart Failure LVEF < 35% Bradycardia |
Heart Failure Heart Diseases Bradycardia Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |