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.

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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.  

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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

QUALITY OF LIFE

33% improvement in MLWHF score
sustained through the 3-year mark.3,4

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

SURVIVAL

87% survival at 3 years for implanted patients.3,5-7

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

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Continue to REDUCE LAP-HF II Trial
  1. Unpublished data on file at Corvia Medical. Data as of January 14, 2022.
  2. 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.
  3. 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).
  4. Unpublished data from REDUCE LAP-HF (n=64). Data on file at Corvia Medical.
  5. 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.
  6. 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.
  7. 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.
  8. Unpublished data from Corvia Pilot Study (n=11). Data on file at Corvia Medical.
  9. 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.
  10. Unpublished data compiled from all Corvia implants as of September 1, 2021. Data on file at Corvia Medical.