Atrioventricular Block Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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