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Ventricular Pacing Site Selection (V-PASS)

Primary Purpose

Atrioventricular Block

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrioventricular Block focused on measuring Cardiac Pacing, artificial, Atrial Fibrillation, Heart failure, Pacemaker leads, Lead position, Higher degree AV-Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzzentrum Bad Krozingen, ElektrophysiologieRecruiting
  • Universitätsklinikum Heidelberg, Innere Medizin III
  • Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
electrical specific values in both groups
energy consumption, lead impedance
Rhythmologic characteristics in both groups
amount of VESs
episodes of ventricular tachycardia
amount of atrial and ventricular stimulation
BNP-levels in both groups
incidence of co-morbidities in both groups
Atrial Fibrillation, AF burden >1%
Heart failure > NYHA II
Hospitalizations in both groups due to
Heart failure
Rhythm disorders

Full Information

First Posted
February 14, 2006
Last Updated
August 1, 2011
Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00292383
Brief Title
Ventricular Pacing Site Selection (V-PASS)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic BRC
Collaborators
Vitatron GmbH

4. Oversight

5. Study Description

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.
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block
Keywords
Cardiac Pacing, artificial, Atrial Fibrillation, Heart failure, Pacemaker leads, Lead position, Higher degree AV-Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Leads to be implanted according randomization on specified sites. Vitatron pacemakers to be implanted: T60 DR, T70 DR, T20 SR, C60 DR
Primary Outcome Measure Information:
Title
Amount of patients in which the ventricular lead position could be positioned successfully according randomization
Secondary Outcome Measure Information:
Title
Typical values re operation procedure in both groups
Title
operation time, x-ray time
Title
intraoperative measurements (amplitudes, thresholds)
Title
broad QRS-complexes in both groups
Title
safety of therapy, complications
Title
electrical specific values in both groups
Title
energy consumption, lead impedance
Title
Rhythmologic characteristics in both groups
Title
amount of VESs
Title
episodes of ventricular tachycardia
Title
amount of atrial and ventricular stimulation
Title
BNP-levels in both groups
Title
incidence of co-morbidities in both groups
Title
Atrial Fibrillation, AF burden >1%
Title
Heart failure > NYHA II
Title
Hospitalizations in both groups due to
Title
Heart failure
Title
Rhythm disorders

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias E Reimers, Dipl. Documentalist
Phone
0049021152930
Ext
422
Email
Matthias.reimers@vitatron.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steffen Gazarek, Dr., Engineer
Phone
004901729135662
Email
steffen.gazarek@vitatron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochem F. Stockinger, MD
Organizational Affiliation
Herzzentrum Bad Krozingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Bad Krozingen, Elektrophysiologie
City
Bad Krozingen
ZIP/Postal Code
D-79189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochem Stockinger, MD
Phone
0049 07633402
Ext
248
Email
JFStockinger@gmx.de
First Name & Middle Initial & Last Name & Degree
Jochem Stockinger, MD
First Name & Middle Initial & Last Name & Degree
Thomas Blum, MD
Facility Name
Universitätsklinikum Heidelberg, Innere Medizin III
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Bauer, MD
Phone
++49 0622563
Ext
8672
Email
Alexander.Bauer@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Alexander Bauer, MD
Facility Name
Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.
City
Wangen
ZIP/Postal Code
D-88239
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jörg Maurus, MD
Phone
0049 00752296
Ext
1311
First Name & Middle Initial & Last Name & Degree
Jörg Maurus, MD

12. IPD Sharing Statement

Citations:
Citation
Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003 http://www.pacemaker-register.de/pdf/zentralregister_herzschrittmacher_bericht03.pdf
Results Reference
background
Citation
DÄNISCHES HERZSCHRITTMACHERREGISTER http://www.pacemaker.dk
Results Reference
background
Citation
SCHWEIZER HERZSCHRITTMACHERREGISTER http://www.pacemaker.ch
Results Reference
background
PubMed Identifier
16200488
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
12063369
Citation
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.
Results Reference
background
PubMed Identifier
15189516
Citation
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.
Results Reference
background
PubMed Identifier
27515355
Citation
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.
Results Reference
background
PubMed Identifier
9193029
Citation
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.
Results Reference
background

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Ventricular Pacing Site Selection (V-PASS)

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