Reducing Lung CongestIon Symptoms in Advanced Heart Failure
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/6/2018 |
| Start Date: | September 19, 2018 |
| End Date: | May 1, 2025 |
| Contact: | Russell Ivanhoe, MD |
| Email: | russell@vwavemedical.com |
| Phone: | +1(818)629-2164 |
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
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 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.
effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical
outcomes in patients with New York Heart Association (NYHA) functional 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.
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 400
patients will be randomized. Patients 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 once unblinded, 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.
study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 400
patients will be randomized. Patients 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 once unblinded, 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.
Main Inclusion Criteria:
- Both heart failure with reduced ejection fraction (HFrEF) and heart failure with
preserved ejection fraction (HFpEF) patients
- NYHA Class III or ambulatory Class IV HF
- Receiving guideline directed medical therapy (GDMT) for heart failure
- At least one prior hospitalization for heart failure within the last year or elevated
BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml.
BNP/NT-ProBNP levels corrected for BMI
Main Exclusion Criteria:
- Systolic blood pressure <90 or >160 mmHg
- Presence of Intracardiac thrombus
- Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR > 4 WU
- Significant RV dysfunction - TAPSE <12mm or RVFAC ≤30%
- Left Ventricular End-Diastolic Diameter (LVEDD) >8cm
- Moderate to severe aortic or mitral stenosis
- Stroke or TIA or DVT within the last 6 months
- eGFR <25 ml/min/1.73 m^2
- Anatomical anomaly on TEE or ICE that precludes implantation of Shunt across fossa
ovalis (FO) of the interatrial septum
- Inadequate vascular access for implantation of shunt, e.g. femoral venous access for
transseptal catheterization and inferior vena cava (IVC) is not patent
- Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion
Criteria
We found this trial at
2
sites
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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