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The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of ventricular desynchronisation.
Full description
The study will be performed as a controlled, single-blind, international, multicenter, prospective, randomized, parallel group design.
In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing, the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular (right ventricular) stimulation, as it has been the standard outside of clinical studies until so far.
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Inclusion criteria
Presence of an indication for ventricular pacing according to the actual guidelines for the implantation of cardiac pacemakers and a need for frequent (or even permanent) ventricular pacing for:
Any QRS duration and morphology
Left ventricular ejection fraction (LVEF) without limit as measured by echocardiography (in at least one plane, either 4- or 2-chamber or apical long axis view)
Signed written informed consent of the patient or a first-degree relative for study participation after informing the patient/relative about the risks and the aim of the study
Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.
Absence of an implanted ventricular pacing device (patients with atrial pacemakers and new need for ventricular pacing may be included)
Exclusion criteria
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Allocation
Interventional model
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1,833 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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