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Study Status: 
Open
Study Description: 


Study Name: RELIEVE-HF

Study Objective: To evaluate safety/efficacy of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from HF.

Key Inclusion Criteria:

 1. Ischemic or non-ischemic cardiomyopathy

2. NYHA Class III or amb Class IV HF

3. Receiving guideline directed medical therapy

4. Prior HF Hosp >24 hours or ER HF Visit with duration ≥6 hours, or HF Clinic ADHF Visit with

     duration ≥6 hours, within 12 months

5. 6MWT ≥100 meters and ≤450 meters

 Key Exclusion Criteria:

1. BMI >45 4. Resting SBP <90 or >160 mmHg

2. PA systolic pressure >70 mmHg

3. (LVEDD) >8cm

4. Mod-sev MS or AS

5. Acute MI, ACS, PCI, or other major surgery within 3 months of baseline visit

6. Stroke, TIA, DVT within 6 months of baseline visit

 

Study Contacts: PI: Maria Karas, MD (646) 962 5555

                           RC:  Katelyn Bastert,   (212) 746 2698 

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Weill Cornell Medicine
Division of Cardiology

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Starr 443
New York, NY 10021

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New York, NY 10021