BIO-AffectDX: Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System

  • STATUS
    Not Recruiting
  • sponsor
    Biotronik, Inc.
Updated on 25 May 2022
heart failure
persistent atrial fibrillation

Summary

The purpose of the BIO-AffectDX Study is to prospectively evaluate improvement from baseline in heart failure subjects with atrial fibrillation (AF) implanted with a two-lead CRT-DX system, with emphasis on a comparison of patient outcomes between AF subtypes.

Description

There is a need for more evidence about the benefits of Cardiac Resynchronization Therapy (CRT) in a patient population with heart failure and atrial fibrillation. The BIO-AffectDX Study will gather information about adults with heart failure and atrial fibrillation who are treated with a CRT-DX device from many locations across the United States. The BIO-AffectDX Study will look at the results of treatment in participants with the primary goal to evaluate the improvement in overall health prior to device implant through 12 months. Overall health will be measured by your study doctor for AF improvement, physical fitness, and general quality of life.

Details
Condition Heart Failure, Atrial Fibrillation
Clinical Study IdentifierTX290322
SponsorBiotronik, Inc.
Last Modified on25 May 2022

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