Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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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.
1. Pilotphase It shall be determined whether a randomized positioning of ventricular leads at 2 defined positions (either Group A: Positioning at right ventricular apex or Group B:. Positioning at right ventricular high septum) is feasible. Included patients will already by examined and followed according to protocol. After having proved feasibility of randomized positioning, the data of these patients shall be used for evaluation of the V-PASS study.
2. Study Phase It shall be evaluated how far 2 defined different ventricular lead positions for permanent pacemaker therapy can influence the combined study endpoint mortality and clinically relevant symptoms of heart failure. Further more the development of hemodynamics and the incidence of atrial fibrillation shall be studied.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
Eligibility Criteria
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Inclusion Criteria
* Symptomatic first-degree AV block, PQ time \>250ms
* Second-degree Av block with permanent 2:1 conduction
* Permanent third-degree AV block
* Paroxysmal first-degree to third-degree Av block, with an anticipated rate of ventricular stimulation \>60%
* Symptomatic bradyarrhythmia absoluta with permanent atrial fibrillation, with an anticipated rate of ventricular stimulation \>60%
Exclusion Criteria
* Intra-atrial conduction delay (P-wave \> 150ms)
* Myocardial infarction less then 6 months before pacemaker implant
* hypertrophic obstructive cardiomyopathy
* Cardiogenic shock
* pregnancy
* Lactation period
* Patients under 18 years of age
18 Years
ALL
No
Sponsors
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Vitatron GmbH
INDUSTRY
Medtronic BRC
INDUSTRY
Principal Investigators
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Jochem F. Stockinger, MD
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum Bad Krozingen
Locations
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Herzzentrum Bad Krozingen, Elektrophysiologie
Bad Krozingen, , Germany
Universitätsklinikum Heidelberg, Innere Medizin III
Heidelberg, , Germany
Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.
Wangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Jörg Maurus, MD
Role: primary
References
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Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf
DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk
SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch
Lemke B, Nowak B, Pfeiffer D; Deutschen Gesellschaft fur Kardiologie--Herz- und Kreislaufforschung e.V. Bearbeitet im Auftrag der Kommission fur Klinische Kardiologie. [Guidelines for heart pacemaker therapy]. Z Kardiol. 2005 Oct;94(10):704-20. doi: 10.1007/s00392-005-0269-3. No abstract available. German.
Gregoratos G., Abrams J. Epstein AE, et al. ACC/AHA /NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee on Pacemaker Implantation)(2002). http://www.acc.org/clinical/guidelines/pacemaker/pacemaker.pdf
Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.
Frohlig G, Schwaab B, Kindermann M. Selective site pacing: the right ventricular approach. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):855-61. doi: 10.1111/j.1540-8159.2004.00547.x.
Koglek W, Kranig W, Kowalski M, Kronski D, Brandl J, Oberbichler A, Suntinger A, Wutte M, Grimm G, Grove R, Ludorff G. [A simple method for AV-delay determination in dual chamber pacemakers]. Herzschrittmacherther Elektrophysiol. 2000 Dec;11(4):244-53. doi: 10.1007/s003990070023. German.
Giudici MC, Thornburg GA, Buck DL, Coyne EP, Walton MC, Paul DL, Sutton J. Comparison of right ventricular outflow tract and apical lead permanent pacing on cardiac output. Am J Cardiol. 1997 Jan 15;79(2):209-12. doi: 10.1016/s0002-9149(96)00718-7.
Other Identifiers
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V-PASS V.1.2.
Identifier Type: -
Identifier Source: org_study_id
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