The company will enrol up to 400 HF patients with paroxysmal, persistent and long-standing persistent AF, at up to 50 sites in the US
Germany-based Biotronik has enrolled first patients in the BIO-AffectDX trial of cardiac resynchronisation therapy (CRT) in patients with heart failure (HF) and atrial fibrillation (AF).
The biomedical technology company intends to enrol up to 400 participants in the multi-centre, observational trial, at up to 50 sites across the US.
BIO-AffectDX will enrol HF patients with paroxysmal, persistent and long-standing persistent AF, and a standard CRT-D indication, as per current guidelines.
Participants will be implanted with a BIOTRONIK Acticor CRT-DX system (CRT-DX pulse generator and a DX ICD lead) and any commercial left ventricular (LV) lead.
The study is designed to assess the rate of participants showing improvement from baseline using a Clinical Composite Score (CCS) at 12 months, as the primary endpoint.
Also, it will evaluate the conversion to sinus rhythm at any time during the 12-month follow-up period, to identify long-term benefits of CRT in the study population, said the company.
Ventura California Community Memorial Hospital cardiac electrophysiology director Jonathan Dukes has enrolled the first patient in the trial.
Jonathan Dukes said: “The current data do not offer us a complete picture of the effectiveness of CRT, particularly in regards to our AF patients.
“Our current CRT practice strategies for this unique population have been predominately based on expert opinion, and additional outcome data are needed to clarify the optional approach to CRT and heart failure management in our AF patients.”
According to the company, HF and AF frequently co-exist and the simultaneous presence of both the disorders elevates the patient’s risk for mortality.
Early clinical trials of CRT technology excluded patients with AF, generating limited data to establish a benefit and guidelines for using the technology in the AF population.
The research had evidence gaps related to effectiveness of CRT in patients with paroxysmal, persistent and permanent AF, along with atrioventricular (AV) node ablation.
University of Cincinnati centre for electrophysiology director Alexandru Costea said: “The BIO-AffectDX trial will gather information about atrial activity with a two lead CRT system. Not only the procedure time goes down but also the potential for complications is reduced dramatically.”
In September 2019, Biotronik has entered into commercial partnership with Proximo Medical for its peripheral vascular intervention (PVI) platform in select US markets.