Investing in Clinical Studies and Peer-Reviewed Evidence

Clinical Research

The RELIEVE-HF Clinical Study

In 2018, V-Wave received regulatory approval to conduct a large clinical trial named RELIEVE-HF (ClinicalTrials.gov ID NCT03499236).  This study will determine the effects of the V-Wave Ventura® Interatrial Shunt System on patients with heart failure, potentially reducing the need for hospitalization and improving symptoms, exercise capacity, and quality of life.

The Study Design

The RELIEVE-HF clinical research study will enroll at least 500 patients at up to 120 clinical sites around the world.  Patients will be assigned at random to either (a) treatment with the shunt plus standard medical care or (b) treatment with standard medical care alone.  Neither the patient nor their physician will know the assignment until the completion of the randomized phase of the study.  For patients randomized to standard medical care alone, they will have an option for a shunt implant available at the end of the randomized phase of the trial if they remain eligible for the study.

For more information on this study, please visit clinicaltrials.gov.

Ready to Learn More?

Visit our patient information website on the RELIEVE-HF clinical study

V-Wave is committed to leading with clinical evidence in interatrial shunting.  We understand that our novel technology will have the greatest impact when paired with evidence that demonstrates improvement in patient symptoms and clinical outcomes.

William Abraham, MD, FACP, FACC, FAHA, FESC, FRCPE

Chief Medical Officer (CMO), V-Wave Ltd.

Additional Clinical Studies

The RELIEVE-PAH Clinical Study

In 2020, V-Wave received regulatory approval to start a limited clinical trial named RELIEVE-PAH (ClinicalTrials.gov ID NCT03838445).  This study will establish first-in-human experience with the V-Wave Ventura Interatrial Shunt System on patients with severe pulmonary arterial hypertension (PAH), including evidence of initial safety, device performance, and possible signals of clinical effectiveness.

The Study Design

The RELIEVE-PAH clinical research study will enroll up to 20 patients at participating sites in North America.  This is a single-arm trial, meaning that all patients will receive a study device implant.  Patients will be monitored for up to five (5) years.

For more information on this study, please visit clinicaltrials.gov.

Prior Clinical Publications

Guimarães L, Bergeron S, Bernier M, et al. Interatrial shunt with the second-generation V-Wave system for patients with advanced chronic heart failure. EuroIntervention. 2020;15(16):1426-1428. doi:10.4244/EIJ-D-19-00291

Rodés-Cabau J, Bernier M, Amat-Santos IJ, et al. Interatrial Shunting for Heart Failure: Early and Late Results From the First-in-Human Experience With the V-Wave System. JACC Cardiovasc Interv. 2018;11(22):2300-2310. doi:10.1016/j.jcin.2018.07.001

Del Trigo M, Bergeron S, Bernier M, et al. Unidirectional left-to-right interatrial shunting for treatment of patients with heart failure with reduced ejection fraction: a safety and proof-of-principle cohort study. Lancet. 2016;387(10025):1290-1297. doi:10.1016/S0140-6736(16)00585-7

MP0010 Rev. 00 DCO 670.