Ventricular Pacing Site Selection (V-PASS)
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ClinicalTrials.gov Identifier: NCT00292383 |
Recruitment Status
: Unknown
Verified October 2007 by Medtronic BRC.
Recruitment status was: Recruiting
First Posted
: February 15, 2006
Last Update Posted
: August 2, 2011
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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 |
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.
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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292383
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 | 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 |
Principal Investigator: | Jochem F. Stockinger, MD | Herzzentrum Bad Krozingen |
Publications:
ClinicalTrials.gov Identifier: | NCT00292383 History of Changes |
Other Study ID Numbers: |
V-PASS V.1.2. |
First Posted: | February 15, 2006 Key Record Dates |
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 |