This study will evaluate the V-Wave Ventura Interatrial shunt. The Shunt is a small, hourglass-shaped device implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart placed during a minimally invasive cardiac catheterization procedure. The hourglass shape of the device holds the Shunt in place. The small opening in the center allows a small amount of blood to flow (to be shunted) from the top left chamber to the top right chamber of the heart. By "shunting" this small amount of blood, the increased pressure in the left side of the heart is reduced, which is expected to reduce congestion in the lungs and improve your symptoms of heart failure.
A previous study, the REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure (RELIEVE-HF) trial showed that implantation of an interatrial shunt device was safe. In that study, patients whose heart pumping function (left ventricular ejection fraction, or LVEF) was \>40% did not have better HF outcomes, such as hospitalization or even death after getting the device. However, the study looked separately at the LVEF ≤40% group and found that patients with an LVEF ≤40% showed improvements in these HF outcomes, as well as fewer episodes of worsening HF requiring an artificial heart pump. This suggests the shunt may help people whose heart pump is reduced, but more information is needed. The purpose of this study is to add to the data on the safety and whether the shunt works in preventing worsening heart failure for patients with reduced pumping strength or LVEF ≤40% .
This study is a multi-center, randomized, patient and observer blinded trial, with three (3) patients randomized to received the shunt (Treatment arm) for every two (2) non-implant Placebo-Procedure (Control patients). A total of approximately 250 patients will be randomized. Patients and research staff managing patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. All patients (Randomized to Treatment and Control) will be followed for a total of 3 years from the time of the randomization for comparison. Follow-up visits will be performed for the study will be conducted in clinic with the research doctors and staff and will include some telephone/remote visits. Patients randomized to the Control group who still meet inclusion/without exclusion criteria and consent will have an opportunity to receive the shunt if the effectiveness endpoint is met at primary study results.
Heart failure with a reduced LV ejection fraction (≤40%) and documented heart failure for at least 6 months from Baseline Visit.
NYHA Class III symptoms
An inhibitor of the renin-angiotensin system (RAS inhibitor), including an angiotensin receptor-neprilysin inhibitor (ARNI), angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and an evidence-based beta-blocker (BB) for at least 3 months prior to the Baseline Visit
An SGLT2I Inhibitor for at least 1 month prior to the Baseline Visit
Resting systolic blood pressure <90 or >160 mmHg
Baseline echocardiographic evidence of intracardiac blood clot, significant right ventricular dysfunction or severe left sided dilation.
Diagnosis of severe pulmonary hypertension.
Congenital Atrial septal defect, patent foramen ovale, with known shunting on echo
Parallel
Implantation of the V-Wave Interatrial shunt
DeviceImplantation of the Ventura Shunt should be performed only by physicians experienced in transseptal cardiac catheterization procedures and trained in the proper use of the Shunt and Delivery System. Perform a standard right heart catheterization and (TEE) or (ICE) echo imaging to assess adequacy of vascular access, cardiovascular anatomy and to rule out potential contraindications. Perform a transseptal puncture, attempting to cross near the center of the fossa ovalis or where anatomy is most suitable. Advance the Delivery System and verify the tip is in the mid left atrium. Deploy the left portion of the Shunt which will be visible on echo or fluoroscopy. Slowly retract the Introducer and the Delivery System as a unit, until the left atrial cone of the Shunt contacts the left side of the fossa ovalis. Release the shunt from the delivery system, and retract until the Shunt is deployed across the fossa ovalis. Shunt placement is verified by fluoroscopic and echo observations.
Sham (no implant)
DeviceStudy procedures should be performed only by physicians experienced in the RELIEVE-HFrEF study protocol and manual of operations. Perform a standard right heart catheterization and transesophogeal (TEE) or intracardiac (ICE) echo imaging to assess adequacy of vascular access, cardiovascular anatomy and to rule out potential contraindications. If eligible and randomized to control, the transseptal and shunt implantation will not be performed but the Interventionalist will simulate the procedure to maintain participant blinding.
Primary Safety
The percentage of Treatment Group patients experiencing device-related Major Adverse Cardiovascular and Neurological Events (MACNE) during the first 30 days after randomization, compared to a pre-specified Performance Goal.
Primary Effectiveness
A composite of time to all-cause mortality or Heart Transplantation/LVAD implantation (HT/LV) and recurrent heart failure hospitalizations. This endpoint will be evaluated utilizing a Bayesian joint frailty model with two components: 1) time to all- cause mortality or HT/LV; and 2) rate of recurrent heart failure hospitalization. A shared parameter for the risk ratio will quantify the treatment benefit of Treatment versus Control across both components. The primary analysis model will also incorporate Bayesian borrowing on the shared treatment effect from the corresponding subgroup in the RELIEVE-HF trial (≤40%). The prior information will be down weighted using Bayesian power prior methodology, and simulations will be used to calibrate the decision criteria and weighting of the prior information to be pre-specified in the Statistical Analysis Plan. This includes a comprehensive evaluation of statistical power and Type I error of the primary analysis with Bayesian borrowing.
Secondary Effectiveness
Heart failure hospitalizations adjusted for all-cause mortality and HT/LV by joint frailty
Secondary Effectiveness
Primary endpoint inclusive of worsening HF treated as an outpatient (WHF)
Secondary Effectiveness
Primary endpoint replacing HFH with All-cause hospitalization (non-elective)
Secondary Effectiveness
Time to all-cause death or HT/LV
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V-Wave Ltd
Lead sponsor
Johnson & Johnson
Collaborator
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