Ventricular Pacing Site Selection (V-PASS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Medtronic BRC.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Vitatron GmbH
Information provided by:
Medtronic BRC
ClinicalTrials.gov Identifier:
NCT00292383
First received: February 14, 2006
Last updated: August 1, 2011
Last verified: October 2007
  Purpose

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
Endpoint Classification: Efficacy Study
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292383

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

Publications:
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Block

ClinicalTrials.gov processed this record on April 17, 2014