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Ventricular Pacing Site Selection (V-PASS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Medtronic BRC.
Recruitment status was:  Recruiting
Vitatron GmbH
Information provided by:
Medtronic BRC Identifier:
First received: February 14, 2006
Last updated: August 1, 2011
Last verified: October 2007
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Medtronic BRC:

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

Estimated Enrollment: 100
Estimated Study Completion Date: December 2008
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00292383

Contact: Matthias E Reimers, Dipl. Documentalist 0049021152930 ext 422
Contact: Steffen Gazarek, Dr., Engineer 004901729135662

Herzzentrum Bad Krozingen, Elektrophysiologie Recruiting
Bad Krozingen, Germany, D-79189
Contact: Jochem Stockinger, MD    0049 07633402 ext 248   
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   
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
Principal Investigator: Jochem F. Stockinger, MD Herzzentrum Bad Krozingen
  More Information

Fachgruppe Herzschrittmacher. Bericht des Deutschen Herzschrittmacher Registers 2003
Lemke B., Nowak B. Pfeiffer D. Leitlinien zur Herzschritmachertherapie. Deutsche Gesellschaft für Kardiologie 2005.
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. Identifier: NCT00292383     History of Changes
Other Study ID Numbers: V-PASS V.1.2.
Study First Received: February 14, 2006
Last Updated: August 1, 2011

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 processed this record on July 21, 2017