Atrial fibrillation associated with heart failure treated by a 2-lead CRT-DX system (BIO-AffectDX): Study design and
Jonathan C Hsu1, Aaron B Hesselson2, Jackson J Liang3
1Cardiac Electrophysiology Section, Division of Cardiology, Department of Medicine, University of California, San Diego, La Jolla, California.
Insights
This study prospectively evaluates cardiac resynchronization therapy (CRT) in heart failure (HF) patients with atrial fibrillation (AF). It assesses improvements in a clinical composite score at 12 months post-implant.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Devices
Background:
- Limited prospective data exists for cardiac resynchronization therapy (CRT) in patients with heart failure (HF) and atrial fibrillation (AF).
- Existing evidence primarily relies on retrospective analyses, necessitating contemporary, prospective cohort data.
Purpose of the Study:
- To characterize changes from baseline in HF patients with AF receiving a 2-lead CRT-DX system.
- To evaluate the primary objective: the percentage of subjects showing improvement in a clinical composite score from pre-CRT to 12 months post-implant.
Main Methods:
- A prospective, observational, multicenter clinical trial enrolling approximately 400 subjects in the US.
- Follow-up includes assessments, atrial rhythm status, and device interrogation at 3, 6, and 12 months post-implant.
Main Results:
- A Clinical Events Committee will adjudicate HF events, arrhythmias, and deaths.
- Independent physician review of site data and device interrogation will inform decisions.
Conclusions:
- The BIO-AffectDX study aims to offer insights into CRT outcomes for patients with both HF and AF.
- This research addresses the need for prospective data in this specific patient population.
Background:
Evidence to support use of cardiac resynchronization therapy (CRT) among patients with both heart failure (HF) and atrial fibrillation (AF) is largely limited to retrospective or post hoc subanalyses. Data from a prospectively enrolled and contemporary cohort are needed.
Objective:
We aim to better characterize the changes from baseline in HF patients with concomitant AF subsequently implanted with a 2-lead CRT-DX system capable of sensing in the atrium, aggregating diagnostics, and delivering CRT therapy. The primary objective of this study is to evaluate the percentage of all HF subjects with an improvement in a clinical composite score from pre-CRT implant to 12 months.
Methods:
The study is a US-based, prospective, observational multicenter clinical trial conducted at up to 50 sites and enrolling approximately 400 subjects with a follow-up period of 1 year. Multiple subject assessments, atrial rhythm status, and device interrogation will be collected at follow-up visits occurring at 3, 6, and 12 months postimplant.
Results:
A Clinical Events Committee will adjudicate subject HF events, arrhythmia events, death events, and all device-classified ventricular tachycardia and ventricular fibrillation episodes with treatment that are collected throughout the follow-up period. Their decisions are based on independent physician review of the data from sites and device interrogation.
Conclusion:
The BIO-AffectDX study aims to provide further insight into the expected outcomes from CRT treatment in patients with HF and AF.
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