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Sponsors and Collaborators: |
Medtronic BRC Vitatron GmbH |
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Information provided by: | Medtronic BRC |
ClinicalTrials.gov Identifier: | NCT00292383 |
The purpose of this study is to determine whether there is a relationship between ventricular lead position and the incidence of heart failure and atrial fibrillation in patients with indication for permanent pacemaker stimulation.
Condition | Intervention | Phase |
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Atrioventricular Block |
Procedure: Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Prospective Multicenter Pilot Study to Determine the Influence of the Ventricular Pacing Site on the Incidence of Atrial Fibrillation and Heart Failure in Patients With Indication for Permanent Pacemaker Stimulation Therapy. |
Estimated Enrollment: | 100 |
Estimated Study Completion Date: | December 2008 |
AV-Block of higher degree is the primary indication for pacing therapy for about 20% of pacemaker patients. Pacing systems with only ventricular stimulation (VVI and VDD) have a fraction of about 40% of all pacemakers in Germany. About 50% of the implanted pacemakers in Germany are dual-chamber pacemakers and one half of them is used for treatment of AV blocks.
Picture 1: Fractions of pacing indications in Germany Picture 2: Fractions of used pacing modes in Germany /1/
A lot of studies proved in the past that the pacing site influenced the development of hemodynamics, heart failure (HF) and atrial fibrillation (AF).
Unfortunately, the results are not commonly applicable or statistically assured. Due to this, further examinations are required in order to get explicit statements regarding application of alternative, nonapical ventricular lead positioning.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with an expected ventricular stimulation rate of >60% in planned pacing therapy. This will be the following pacing indications
Exclusion Criteria:
Contact: Matthias E Reimers, Dipl. Documentalist | 0049021152930 ext 422 | Matthias.reimers@vitatron.com |
Contact: Steffen Gazarek, Dr., Engineer | 004901729135662 | steffen.gazarek@vitatron.com |
Germany | |
Herzzentrum Bad Krozingen, Elektrophysiologie | |
Bad Krozingen, Germany, D-79189 | |
Universitätsklinikum Heidelberg, Innere Medizin III | |
Heidelberg, Germany, D-69120 | |
Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med. | |
Wangen, Germany, D-88239 |
Principal Investigator: | Jochem F. Stockinger, MD | Herzzentrum Bad Krozingen |
Study ID Numbers: | V-PASS V.1.2. |
Study First Received: | February 14, 2006 |
Last Updated: | October 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00292383 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Cardiac Pacing, artificial Atrial Fibrillation Heart failure |
Pacemaker leads Lead position Higher degree AV-Block |
Heart Failure Heart Diseases Heart Block Atrioventricular Block |
Atrial Fibrillation Enfuvirtide Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Heart Block Cardiovascular Diseases |
Atrioventricular Block Atrial Fibrillation Arrhythmias, Cardiac |