Clinical Studies

 

REDUCE LAP-HF II Study

Currently enrolling patients in a multicenter, randomized, controlled pivotal study of the IASD®System II for treatment of patients suffering from heart failure with preserved ejection fraction (HFpEF) and mid-range ejection fraction (HFmrEF).

Visit treatmyheartfailure.com or clinicaltrials.gov to learn more.

 

Post-Market Registry

The IASD study is intended to evaluate the clinical utility of the Corvia IASD System for interatrial shunting in a “Real-World” patient population with heart failure with preserved ejection fraction (or mildly reduced ejection fraction). Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat patients with HFpEF or HFmrEF. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

 

HFrEF Feasibility Study

Currently enrolling patients in a prospective, non-randomized, single-arm feasibility trial that will include up to 10 subjects. The population will include heart failure patients with reduced ejection fraction, and elevated left sided filling pressures, who remain symptomatic despite GDMT, including optimal doses of recommended pharmaceutical treatments, surgical, and device intervention(s) (CRT, AICD, reduction of MRI).

Visit clinicaltrials.gov to learn more.

 

REDUCE LAP-HF I Study

Published randomized controlled study of the the IASD® System II for treatment of patients suffering from heart failure with preserved ejection Fraction (HFpEF) demonstrated significantly lowered Pulmonary Capillary Wedge Pressure (PCWP) during peak exercise at 1 month follow-up. Longer-term follow-up is ongoing.

Read the published results here.

 

REDUCE LAP-HF study

Published observational study of the the IASD® System II for treatment of patients suffering from heart failure with preserved ejection fraction (HFpEF) demonstrated significant improvement in Quality of Life (QoL) metrics sustained at 12 months.

Read the published results here.

  1. Kaye D., HasenfußG., NeuzilP., et al. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016.
  2. HasenfußG., Hayward C., BurkhoffD. et al. A Transcatheterintracardiacshunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicenter, open label, single-arm, phase 1 trial. Lancet 2016; 387: 1298–304.

 

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    CAUTION–Investigational Device. Limited by United States Law to Investigational Use.

  • HFpEF Scoring Chart

    Borlaug, Reddy, et al