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Status:

UNKNOWN

Ventricular Pacing Site Selection (V-PASS)

Lead Sponsor:

Medtronic BRC

Collaborating Sponsors:

Vitatron GmbH

Conditions:

Atrioventricular Block

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 p...

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% ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2008

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00292383

End Date

December 1 2008

Last Update

August 2 2011

Active Locations (3)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (3 locations)

1

Herzzentrum Bad Krozingen, Elektrophysiologie

Bad Krozingen, Germany, D-79189

2

Universitätsklinikum Heidelberg, Innere Medizin III

Heidelberg, Germany, D-69120

3

Oberschwaben Klinik GmbH, Krankenhaus Wangen, Innere Med.

Wangen, Germany, D-88239