Last updated on April 2020

READ-ASV Registry - Phase II

Brief description of study

The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

Detailed Study Description

The pilot phase (NCT03032029) enrolled over 200 patients now being analyzed. After completion of the the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 700-1000 patients over a period of 5 years. The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur after the first 12 months of therapy use. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. Each patient will be included for a maximum of 15 months, whereas serious events will be tracked throughout the total duration of phase I and II of the registry.

Clinical Study Identifier: NCT04331821

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Recruitment Status: Open

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