Healthcare Professionals
A Foundation of Clinical Evidence
The Corvia Atrial Shunt is the most clinically studied atrial shunt for the reduction of Left Atrial Pressure (LAP) in HFpEF/HFmrEF patients. Over 750 patients have been studied to date and multiple studies are ongoing.
>550
Corvia Atrial Shunts
implanted globally
>1500
Implanted patient-years of follow-up1
7+
Years post-implant for the longest ongoing Corvia Atrial Shunt patients1
20+
Peer-reviewed publications
on the Corvia Atrial Shunt performance & mechanism of action
REDUCE LAP-HF Clinical Program
Corvia Medical is committed to generating unbiased evidence to support atrial shunting for heart failure in collaboration with its clinical investigators and advisors. Through multiple REDUCE LAP-HF studies around the world, clinical results have consistently established the efficacy and safety of the Corvia Atrial Shunt System in heart failure patients with an EF≥40% and elevated left atrial pressure.
REDUCE LAP-HF II Trial Results
Results from this landmark study are now available! REDUCE LAP-HF II is the largest randomized clinical trial of a device-based therapy in HFpEF and the only study to demonstrate effectiveness of an implantable therapy in this patient population.
Clinical Evidence Summary: Pilot Study, REDUCE LAP-HF, REDUCE LAP-HF I
PWCP REDUCTION
Immediate and significant PCWP reduction of 3-5mmHG with clinical improvement sustained over 12 months.2
HF HOSPITALIZATIONS
69% of implanted patients were free from any HF hospitalization and 91% were free from >1 HF hospitalization through the 3-year mark.4
SAFETY
The Corvia Atrial Shunt demonstrated consistent, durable results in nearly 100 patients across 3 studies.
98%
Freedom from stroke (CVA) @ 3 years7
No
increased
risk
of RV failure
out to 5 years7
100%
Patency @ 1 year3,8,9
0
Cases of implant removal, closure, or thrombosis through 8 years10
- Unpublished data on file at Corvia Medical. Data as of January 14, 2022.
- Feldman T, Mauri L, Kahwash, et al. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I): A Phase 2, Randomized, Sham-Controlled Trial. Circ. 2018;137(4):364-375.
- Kaye DM, Hasenfuß G, Neuzil P, 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 Dec; 9(12).
- Unpublished data from REDUCE LAP-HF (n=64). Data on file at Corvia Medical.
- Malek F, Neuzil P, Gustafsson F, et al. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-28.
- Hasenfuß G, Hayward C, Burkhoff D, et al. A Transcatheter intracardiac shunt 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.
- Unpublished data compiled from Corvia Pilot Study (n=11), REDUCE LAP-HF (n=64), and REDUCE LAP-HF I (n=22 randomized to treatment). Data on file at Corvia Medical.
- Unpublished data from Corvia Pilot Study (n=11). Data on file at Corvia Medical.
- Shah S J, Feldman T, Ricciardi MJ, et al. One-Year Safety and Clinical Outcomes of a Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction in the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (REDUCE LAP-HF I) Trial: A Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):968-977.
- Unpublished data compiled from all Corvia implants as of September 1, 2021. Data on file at Corvia Medical.