Clinical Trial TitleRELIEVE-HF Trial: REducing Lung congestion symptoms using the v-wavE shunt in adVancEd Heart Failure.
Clinical Trial Protocol Description:
The purpose of this randomized double-blinded study is to examine the safety and efficacy of the V-Wave Interatrial Shunt by improving clinical outcomes in patients with advanced, symptomatic heart failure. The V-Wave Shunt is a permanent medical device implanted between the right and left atria. It is intended to reduce left atrial pressure and thus, potentially reduce symptoms and frequency of heart failure hospitalizations. The study will enroll up to 500 subjects from 75 sites Worldwide. Rush University Medical Center is anticipating to enroll 10 patients per year.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have a diagnosis of ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months.
- Are NYHA Class III or ambulatory Class IV HF.
- Are currently receiving guideline directed medical therapy for heart failure.
You will be excluded from the study if any of the following criteria apply to you:
- Have a BMI >40 or <18 kg/m2.
- Have resting systolic blood pressure <90 or >160 mmHg after repeated measurements.
This is a partial list of inclusion and exclusion criteria.