Healthcare Professionals
Corvia Clinical Program
Corvia Medical, in collaboration with its clinical investigators and advisors, is committed to generating and sharing unbiased evidence to support atrial shunting therapy for heart failure. Multiple studies have been conducted around the world to evaluate the Corvia Atrial Shunt System for the treatment of HF patients with left atrial pressure who remain symptomatic despite standard Guideline Directed Medical Therapy (GDMT). Several studies, including the recently initiated RESPONDER-HF study, are ongoing.
Studies include the following:
Pilot Study – 2o12
Observational study (n=11)
Evaluate device safety & potential benefit at 30 days
Status: Complete
Results
Evidence of procedural safety and significant PCWP drop at 30 days. NYHA & QoL improvement at 1 yr.
Publications
6-month data
Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Interatrial Implant to Lower Left Atrial Pressure
Søndergaard L, Reddy V, Kaye D, et al. Eur J Heart Failure 2014; 16:796-8.
1-year data
Clinical Outcome of Transcatheter Treatment of Heart Failure with Preserved or Mildly Reduced Ejection Fraction Using a Novel Implant
Malek F, Neuzil P, Gustafsson F, et al. International Journal of Cardiology 2015; 187:227–28.
REDUCE LAP-HF – 2o14
Observational study (n=64)
Understand device safety & therapy performance in a larger patient cohort
Status: Complete
Results
Evidence of sustained PCWP drop and device patency at 6 & 12 months. Significant and sustained 6MWT, QoL and NYHA class improvement through 1 year. Suggestion of a potential reduction in mortality in HFpEF at 2 years.
Publications
Trial design
Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial
Hasenfuβ G, Gustafsson F, Kaye D, et al. J Card Fail 2015; 21(7): 594-600.
6-month data
A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicenter, open label, single-arm, phase 1 trial
Hasenfuß G, Hayward C, Burkhoff D, et al. Lancet 2016; 387: 1298–304.
1-year data
One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction
Kaye DM, Hasenfuß G, Neuzil P, et al. Circ Heart Fail. 2016 Dec; 9(12).
2-year data
Impact of an Interatrial Shunt Device on Survival and Heart Failure Hospitalizations in Patients with Preserved Ejection Fraction
Kaye DM, Petrie MC, McKenzie S, et al. ESC Heart Fail. 2019 Feb; 6(1): 62-69.
REDUCE LAP-HF I – 2o16
Randomized, blinded, sham-controlled trial (n=44)
Evaluate peri-procedural safety & device effectiveness against control arm
Status: Complete
Results
Demonstrated mechanistic effect. Improvement in HF events, symptoms, QoL vs. control at 1 year. 100% shunt patency at 1 year.
Publications
1-month data
Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure] A Phase 2, Randomized, Sham-Controlled Trial
Feldman T, Mauri L, Kahwash R, et al. Circulation. 2018 Jan 23;137(4):364-375.
1-year data
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
Shah SJ, Feldman T, Ricciardi MJ, et al. JAMA Cardiol. 2018 Oct 1;3(10):968-977.
REDUCE LAP-HF II – 2o17
Randomized, blinded, sham-controlled trial (n=626)
Evaluate safety & clinical efficacy in powered study
Status: Follow-up
Results
No effect on the primary composite endpoint of cardiovascular death or stroke, HF events, and health status. Robust evidence of clinical benefit in patients with normal exercise pulmonary vascular resistance and no pacemaker.
Publications
Trial Design
Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II)
Berry N, Mauri L, Feldman T,. et al. Am Heart J, 2020; 226:222-31.
Primary Outcome
Atrial Shunt Device for Heart Failure with Preserved and Mildly Reduced Ejection Fraction (REDUCE LAP-HF II): A Randomised, Multicentre, Blinded, Sham-Controlled Trial.
Shah SJ, Borlaug, BA, Chung, ES et al. Lancet. 2022;399(10330):1130-1140.
Responder Group Analysis
Latent Pulmonary Vascular Disease May Alter the Response to Therapeutic Atrial Shunt Device in Heart Failure.
Borlaug, BA, Blair, J, Bergmann, MW et al. Circulation. 2022;10.1161/CIRCULATIONAHA.122.059486.
REDUCE LAP-HF III – 2o17
Prospective, multicenter, international study to collect post market data (n= up to 500)
Further evaluate efficacy, safety, and quality of life outcomes in a “real world” practice setting
Status: Enrolling
Results
TBD
Publications
TBD
RESPONDER-HF – 2022
Randomized, blinded, sham-controlled confirmatory trial (n=260)
Publications
TBD
To learn more about the REDUCE LAP-HF studies
visit www.clinicaltrials.gov