Project

AdaptResponse

Completed · 2016 until 2022

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2022
Financing
Industry
Study Design
Following enrollment and baseline assessment, eligible subjects will be implanted with a CRT system containing the aCRT algorithm and randomized in a 1:1 fashion to either treatment (aCRT ON) or control (aCRT OFF) groups. Study subjects will be followed for a minimum of 24 months or until study closure, whichever comes first. Refer to the figure below for an overview of the study design
Brief description/objective

The AdaptResponse study is a prospective, randomized, controlled, interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization Therapy (CRT) in heart failure (HF) clinical study.

The purpose of this clinical study is to test the hypothesis that market released CRT devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal AV conduction and left bundle branch block (LBBB).