NCT03499236

Reducing Lung CongestIon Symptoms in Advanced Heart Failure

RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: V-Wave Ltd · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

Detailed description

This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	V-Wave Interatrial Shunt	The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovalis and straddles the interatrial septum.
OTHER	Control	Right heart catheterization, invasive echocardiography.

Timeline

• Start date: 2018-09-19
• Primary completion: 2023-10-09
• Completion: 2027-10-31
• First posted: 2018-04-17
• Last updated: 2025-08-19

Locations

83 sites across 11 countries: United States, Australia, Belgium, Canada, Germany, Israel, Netherlands, New Zealand, Poland, Spain, Switzerland

Regulatory

• FDA-regulated device study