Investing in Clinical Studies and Peer-Reviewed Evidence

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). RELIEVE-HF is a prospectively randomized, double-blind, controlled clinical study. This study is assessing the safety and effectiveness of the V-Wave™ Ventura Interatrial Shunt for the treatment of heart failure (HF), with the potential to reduce future HF hospitalizations as well as improve symptoms and quality of life for HF patients.

The Study Design

The RELIEVE-HF clinical research study completed enrollment in October 2022 with 508 randomized patients from 101 clinical sites from 11 countries around the world. Patients were assigned at random to either (a) treatment with the shunt plus standard medical care or (b) treatment with standard medical care alone. Patients and their physicians will remain blinded for 24 months or until the last patient completes 12 months of follow up, whichever comes first. 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. The primary analysis of the randomized cohort will take place after the last randomized patient completes 12 months of follow up, with primary effectiveness follow up ranging from 12 to 24 months.

RELIEVE-HF also included an open label roll-in arm with a cohort of an additional 97 patients, for a total of 605 patients inclusive of both the randomized and roll-in study arms.

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

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.