REDUCE LAP-HF II Clinical Study

UPMC has been selected as a center for the REDUCE LAP-HF II Clinical Study, a prospective, multicenter, pre-market randomized controlled (1:1), blinded study to evaluate the IASD to reduce elevated left atrial pressure in patients with HFpEF.

The goal of the Corvia Medical InterAtrial Shunt Device (IASD®) System II is to improve quality of life and reduce heart failure-related symptoms and events in patients with heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF) with elevated left atrial pressures, and who remain symptomatic despite standard GDMT.

The InterAtrial Shunt Device (IASD) System II is the world’s first transcatheter device designed to treat HFpEF. Our interventionalist will create a small opening in the atrial septum and deploy the device. This will form a passage between the left and right atria that enables the left atrium to decompress with the aim of lowering left atrial pressure. The goal is to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients.

Which patients are eligible?

Potential candidates for REDUCE LAP-HF II must meet the following primary inclusion criteria:

• Chronic symptomatic Heart Failure (HF) documented by
• New York Heart Association (NYHA) Class II, III/ambulatory class IV symptoms or signs
• And one of the following:
• One or more hospital admission for which HF was a major component, or emergency department visit with IV treatment for HF, within past 12 months
• BNP value > 50 pg./ml sinus, > 150 pg./ml in AF within the past six months (NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in AF)
• Ongoing stable GDMT HF management according to the 2016 ACCF/AHA Guidelines
• Left ventricular ejection fraction ≥40 percent within the past three months, without documented ejection fraction <30 percent within the last five years

Contact us

For a full list of inclusion/exclusion criteria or to refer a patient:
Marc Simon, MD, is the principal investigator at UPMC. If you know a patient who may qualify, please call Mary Kunkel, RN, BSN, research nurse coordinator at 412-647-4463 or email HeartFailureClinicalTrials@upmc.edu.