Ventricular Pacing Site Selection (V-PASS)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
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 4

Detailed Description:

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.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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.
Study Completion Date :	December 2008

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Typical values re operation procedure in both groups
2. operation time, x-ray time
3. intraoperative measurements (amplitudes, thresholds)
4. broad QRS-complexes in both groups
5. safety of therapy, complications
6. electrical specific values in both groups
7. energy consumption, lead impedance
8. Rhythmologic characteristics in both groups
9. amount of VESs
10. episodes of ventricular tachycardia
11. amount of atrial and ventricular stimulation
12. BNP-levels in both groups
13. incidence of co-morbidities in both groups
14. Atrial Fibrillation, AF burden >1%
15. Heart failure > NYHA II
16. Hospitalizations in both groups due to
17. Heart failure
18. Rhythm disorders

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

• 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

Contacts and Locations

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Contacts

Contact: Matthias E Reimers, Dipl. Documentalist	0049021152930 ext 422	Matthias.reimers@vitatron.com
Contact: Steffen Gazarek, Dr., Engineer	004901729135662	steffen.gazarek@vitatron.com

Locations

Germany
Herzzentrum Bad Krozingen, Elektrophysiologie	Recruiting
Bad Krozingen, Germany, D-79189
Contact: Jochem Stockinger, MD 0049 07633402 ext 248 JFStockinger@gmx.de
Principal Investigator: Jochem Stockinger, MD
Sub-Investigator: Thomas Blum, MD
Universitätsklinikum Heidelberg, Innere Medizin III	Not yet recruiting
Heidelberg, Germany, D-69120
Contact: Alexander Bauer, MD ++49 0622563 ext 8672 Alexander.Bauer@med.uni-heidelberg.de
Principal Investigator: Alexander Bauer, MD
Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.	Not yet recruiting
Wangen, Germany, D-88239
Contact: Jörg Maurus, MD 0049 00752296 ext 1311
Principal Investigator: Jörg Maurus, MD

Sponsors and Collaborators

Medtronic BRC

Vitatron GmbH

Investigators

Principal Investigator:	Jochem F. Stockinger, MD	Herzzentrum Bad Krozingen

More Information

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Publications:

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. Leitlinien zur Herzschritmachertherapie. Deutsche Gesellschaft für Kardiologie 2005. http://www.dgk.org/leitlinien/LLHerzschrittmacher.pdf

Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008 May 27;51(21):e1-62. doi: 10.1016/j.jacc.2008.02.032. Erratum in: J Am Coll Cardiol. 2009 Apr 21;53(16):1473. J Am Coll Cardiol. 2009 Jan 6;53(1):147.

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.

Fröhlig G, Schwaab B, Kindermann M. Selective site pacing: the right ventricular approach. Pacing Clin Electrophysiol. 2004 Jun;27(6 Pt 2):855-61. Review.

Koglek W, Kranig W, Kowalski M, Kronski D, Brandl J, Oberbichler A, Suntinger A, Wutte M, Grimm G, Grove R, Lüdorff 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.

ClinicalTrials.gov Identifier:	NCT00292383 History of Changes
Other Study ID Numbers:	V-PASS V.1.2.
First Posted:	February 15, 2006
Last Update Posted:	August 2, 2011
Last Verified:	October 2007

Keywords provided by Medtronic BRC:

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

Additional relevant MeSH terms:

Atrial Fibrillation; Atrioventricular Block; Arrhythmias, Cardiac; Heart Diseases	Cardiovascular Diseases; Pathologic Processes; Heart Block