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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: | NCT00157794 |
Right ventricular apical pacing in patients treated with a pacemaker is unnecessary in cases where patients have stable atrioventricular (AV)-conduction. Recent findings demonstrate that pacing even might have unfavourable effects, especially if patients suffer from additional cardiac diseases such as heart failure. The Search AV+ algorithm was designed to avoid ventricular pacing and support intrinsic AV-conduction in order to avoid possible detrimental effects of right ventricular apical pacing. The goal of the EnTRINSIC study is to assess the amount of ventricular stimulation, the amount of hospitalizations, the occurrence of atrial fibrillation and the usage of drugs in patients treated with pacemakers with an activated Search AV+ algorithm versus patients treated with an individual optimization of the pacemaker settings to minimize the amount of right ventricular pacing.
Condition | Intervention | Phase |
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Arrhythmia, Sinus |
Device: Search AV+ algorithm |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | EnPulse Trial on Search AV+ Influence |
Estimated Enrollment: | 300 |
Study Start Date: | February 2004 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Knappschaftskrankenhaus Sulzbach, Medizinische Klinik | |
Sulzbach, Germany, 66280 | |
St. Vincentius Kliniken | |
Karlsruhe, Germany, 76135 | |
Josephs-Hospital | |
Warendorf, Germany, 48231 | |
St. Josefs Hospital | |
Bochum, Germany, 44791 | |
Kreiskrankenhaus Ottweiler | |
Ottweiler, Germany, 66564 | |
Klinikum der Johannes-Gutenberg-Universität | |
Mainz, Germany, 55131 | |
Internistische Praxis Dr. Med. Schade | |
Berlin, Germany, 13187 | |
Praxis Dr. Med. Markert | |
Gaggenau, Germany, 76571 | |
Vinzentius Krankenhaus | |
Landau, Germany, 76829 | |
Städtisches Klinikum Neunkirchen | |
Neunkirchen, Germany, 66538 | |
Universitätsklinikum Heidelberg | |
Heidelberg, Germany, 69120 | |
Krankenhaus Martha Maria Halle | |
Halle, Germany | |
Gemeinschaftspraxis Dr. Tamm/Dr. Hon | |
Wittenberg, Germany | |
Germany, Bavaria | |
Klinikum Großhadern Herzchirurgische Klinik und Poliklinik | |
Munich, Bavaria, Germany, 81377 |
Principal Investigator: | Michael Jakob, MD | Knappschaftskrankenhaus Sulzbach |
Principal Investigator: | Peter Lamm, MD | Klinikum der Universität München Großhadern |
Study ID Numbers: | CEN_G_CA_2 |
Study First Received: | September 9, 2005 |
Last Updated: | May 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00157794 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Sinus Node Disease Pacemaker Dual Chamber Pacemaker |
Heart Diseases Arrhythmia, Sinus Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |