Ventricular Pacing Site Selection (V-PASS)

NCT00292383 | Unknown Phase 4

• 1 other identifier: V-PASS V.1.2.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrioventricular Block

Keywords

Cardiac Pacing, artificial; Atrial Fibrillation; Heart failure; Pacemaker leads; Lead position; Higher degree AV-Block

Outcome Measures

Primary Outcomes (1)

• Amount of patients in which the ventricular lead position could be positioned successfully according randomization

Secondary Outcomes (18)

• Typical values re operation procedure in both groups

• operation time, x-ray time

• intraoperative measurements (amplitudes, thresholds)

• broad QRS-complexes in both groups

• safety of therapy, complications

Interventions

Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an expected ventricular stimulation rate of \>60% in planned pacing therapy. This will be the following pacing indications
• 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%

You may not qualify if:

• heart failure acc. NYHA III or IV
• 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

Sponsors & Collaborators

• Medtronic BRC: lead
• Vitatron GmbH: collaborator

Study Sites (3)

Herzzentrum Bad Krozingen, Elektrophysiologie

Bad Krozingen, D-79189, Germany

RECRUITING

Universitätsklinikum Heidelberg, Innere Medizin III

Heidelberg, D-69120, Germany

NOT YET RECRUITING

Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.

Wangen, D-88239, Germany

NOT YET RECRUITING

Related Publications (9)

• Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf

  BACKGROUND

• DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk

  BACKGROUND

• SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch

  BACKGROUND

• 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.

  PMID: 16200488 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12063369 BACKGROUND

• 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.

  PMID: 15189516 BACKGROUND

• 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.

  PMID: 27515355 BACKGROUND

• 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.

  PMID: 9193029 BACKGROUND

MeSH Terms

Conditions

Atrioventricular Block; Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jochem F. Stockinger, MD

  Herzzentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias E Reimers, Dipl. Documentalist

CONTACT

0049021152930; Matthias.reimers@vitatron.com

Steffen Gazarek, Dr., Engineer

CONTACT

004901729135662; steffen.gazarek@vitatron.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Completion: December 1, 2008
• Last Updated: August 2, 2011

Record last verified: 2007-10

Locations

DE (3)