Why the study?
Evidence supporting CRT in patients with both HF and AF is largely limited to retrospective or post hoc analyses, leaving a need for prospective contemporary data.
Does a 2-lead CRT-DX system improve a clinical composite score in heart failure patients with concomitant atrial fibrillation?
Population
Approximately 400 HF patients with concomitant AF
Comparison
Implantation with a 2-lead CRT-DX system
Design
US-based prospective observational multicenter clinical trial
Follow-up
1 year
Key result
The BIO-AffectDX study is a prospective observational protocol designed to evaluate 12-month clinical composite score improvement in 400 patients with heart failure and atrial fibrillation implanted with a 2-lead CRT-DX system, with no results reported yet.
Authors
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No clinical data yet support 2-lead CRT-DX in HF with AF; this protocol leaves open whether it improves composite scores.
Observational (n=400)
Yes
Does a 2-lead CRT-DX system improve a clinical composite score in heart failure patients with concomitant atrial fibrillation?
The BIO-AffectDX study protocol outlines a prospective observational trial to evaluate the clinical outcomes of a 2-lead CRT-DX system in patients with heart failure and concomitant atrial fibrillation.
Hsu et al. (2021) conducted an observational in Heart failure with concomitant atrial fibrillation (n=400). 2-lead CRT-DX system was evaluated on Percentage of all HF subjects with an improvement in a clinical composite score from pre-CRT implant to 12 months. The BIO-AffectDX study is a prospective observational protocol designed to evaluate 12-month clinical composite score improvement in 400 patients with heart failure and atrial fibrillation implanted with a 2-lead CRT-DX system, with no results reported yet.
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