Landmark HFPEF trial – FirstClinTech played important role
30 March 2016
“The Lancet” describes a landmark HFPEF trial – FirstClinTech played important role in study success.
A recent article published in The Lancet by Hasenfuß et al describes a successful phase 1 trial of a novel interatrial shunt device (IASD, Corvia Medical Inc.) in the treatment of patients with heart failure with preserved ejection fraction. FirstClinTech played an important role in helping the Investigators and their teams recruit patients into the study. The sponsor, Corvia Medical Inc., engaged FirstClinTech to work in partnership with the investigators and the CRO. This helped the heart failure study meet its recruitment goals which is historically challenging in particular in this poorly served patient population. The results of the study showed that implantation of the IASD device (via a transcatheter approach) was feasible, seemed to be safe, and reduced left atrial pressure during exercise – a key management goal in HFpEF. The authors interpreted the data to suggest that the IASD could offer a new strategy for the management of HFpEF. Corvia is now sponsoring a randomized clinical trial to establish effectiveness, and FirstClinTech is delighted to continue assisting the investigators both in patient recruitment and procedural support.
Reference: A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial; Hasenfuß, Gerd et al., The Lancet , Volume 387 , Issue 10025 , 1298 – 1304.
To find out more about Corvia – click Corvia Medical.