RELIEVE-HF Trial: Reducing Lung Congestion Symptoms Using the V-Waveshunt in Advanced Heart Failure

General Information Age Group Adults Status Active Protocol Number Cl7018 Background Information The objective of this study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from HF. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Wayne Batchelor, MD and Kelly Epps, MD Eligibility Information Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV ejection fraction and documented heart failure for at least 6 months from Baseline Visit NYHA Class II, Class III, or ambulatory Class IV HF Receiving guideline directed medical therapy (GDMT) for heart failure Receiving Class I recommended cardiac rhythm management device therapy One (1) prior Heart Failure Hospitalization with duration > 24 hours or Emergency Room Heart Failure Visit with duration ≥ 6 hours, or Heart Failure Clinic ADHF Visit with duration ≥ 6 hours, within 12 months from Baseline Visit. OR ) Alternatively, if patients have not had a HF hospitalization or ER HF Visit within the prior 12 months, they must have a corrected elevated Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml Able to perform the 6 minute walk test with a distance ≥ 100 meters and ≤ 450 meters Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits Ineligibility Information BMI > 45 or < 18kg/m2 Females of childbearing age who are not on contraceptives or surgically sterile, pregnant or lactating mothers Resting systolic blood pressure 160 mmHg after repeated measurements Baseline echocardiographic evidence of unresolved, non-organized or mobile intracardiac thrombus Severe pulmonary hypertension defined as PA systolic pressure > 70 mmHg by echo/Doppler RV dysfunction defined as TAPSE < 12 mm or RVFAC < 25% Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm as assessed on Baseline TTE Atrial septal defect (congenital or iatrogenic), patent foramen ovale, or anomalous pulmonary venous return, with more than trace shunting on color Doppler or intravenous saline contrast (bubble study) or prior surgical or interventional correction of congenital heart disease involving the atrial septum (excluding closure by suture only but including placement of a PFO or ASD closure device) Untreated moderately severe or severe aortic or mitral stenosis Untreated severe or greater regurgitant valve lesions, which are anticipated to require surgical or percutaneous intervention within 12 months Mitral valve repair device (e.g. MitraClip) implanted within 3 months prior to Baseline Visit Untreated coronary stenosis which requires surgical or percutaneous intervention Prior cardiac transplantation For additional information, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03499236 Contact Information Contact Name Katherine Armstrong, CRC Contact Phone 571-472-2918 Contact Email Send Email