The Cardiovascular Institute of Los Robles Health System conducts research for a wide range of cardiovascular disorders and offers patients opportunities to participate in research and clinical trials. Below is more information about clinical trials currently underway at Los Robles.


For patients

To learn more about each study, please see below:

Valve:

Triluminate Trial

  • Minimally invasive treatment for leaky tricuspid valve
  • Los Robles Health System is conducting a clinical research study of the medical device called the “V-Wave Interatrial Shunt” (will be referred to as “shunt”) that is investigational, which means that it is not approved by the Food and Drug Administration (FDA) to be sold.
  • The V-Wave Shunt is developed and manufactured by V-Wave, the study Sponsor. Saibal Kar MD, Vishva Dev MD, Gregory Fontana MD and David Aliabadi MD are the doctors participating in this study.
Why is this research study being done?

The purpose of this study is to evaluate the safety and how well the shunt works. Additionally, the study will look at information obtained from the tests performed to see if you have clinical improvement in your symptoms of heart failure. To evaluate the safety and performance of the shunt, tests will be done specifically for the purpose of this study, which will be detailed below.

Who will be enrolled in the study?

If you are found to be eligible to participate in the trial, during the study intervention procedure, you will be randomly assigned to one of two study groups; either the group that will be implanted with the V-Wave Shunt, or the control group which will not receive the study device initially. If you are a patient randomized to the control group, you will be given the option to receive the shunt at the completion of the blinded phase of the study or at 24 months of follow-up, whichever is sooner, as long as you continue to be eligible to receive the shunt and you consent to receive the shunt. Patients in both groups will continue to receive all guideline recommended heart failure treatment per your heart failure clinicians’ recommendations and both groups will follow the same schedule for study visits and procedures after the randomization. If you are in the control group and are not eligible to receive the Shunt or decide not to receive the Shunt at the end of the blinded phase, your participation in the study will end at that time.

What is the device being tested?
V-Wave Shunt
V-Wave Shunt Implanted

The V-Wave Shunt is a small, hourglass-shaped device with a very small opening in the center of the device. The frame of the device is made of metal (nitinol) and it is covered with a plastic polymer called ePTFE. These materials are both approved for and are commonly used in medical implants.

The shunt is implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart. 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.

For more details about the study please visit the ClinicalTrials.gov website:

Learn more about the Triluminate Trial

Heart failure:

Relieve-HF Trial

  • Treatment for heart failure patients that have not responded to medical therapy

Learn more about the Relieve-HF Trial

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For physicians

To learn more about each study, please see below:

Valve:

Triluminate Trial

  • Minimally invasive treatment for leaky tricuspid valve
  • Interatrial shunting has emerged as a promising investigational therapy for the treatment of heart failure. Los Robles Health System is participating in a landmark clinical study of interatrial shunting, the RELIEVE-HF trial. This trial is evaluating the safety and effectiveness of the V-Wave Ventura Interatrial Shunt in heart failure patients, with either preserved or reduced left ventricular ejection fraction, who remain symptomatic despite standard of care heart failure therapies.
Overview of the clinical need for new treatment in the target population (Background)

Heart Failure (HF) is one of the major public healthcare problems facing the developed world and has profound effects on the utilization of health care resources. HF is a syndrome characterized by high mortality, frequent hospitalization, reduced quality-of-life and a complex therapeutic regimen. In the US, the population with HF is growing. There are now 870,000 newly diagnosed cases and 308,000 deaths per year. There are more than 1 million hospitalizations annually in the US where the primary cause of admission is Acute Decompensated Heart Failure (ADHF) with 80-90% of patients having a history of pre-existing chronic HF. Additionally, there are almost 700,000 Emergency Room visits and at least 6 million office/clinic visits that add societal, logistical and economic burdens to the system. In the coming decades, HF is expected to become an increasingly larger healthcare problem as the population ages. HF is most often an incurable disorder.

Standard of care treatment

The mainstay therapy for HFrEF patients are medications that regulate the neurohormonal milieu or heart rate. These drug classes include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, neprilysin inhibitors, beta blockers, mineralocorticoid inhibitors, and ivabradine. These agents have been demonstrated in randomized trials to reduce morbidity and mortality and in some cases to result in beneficial ventricular remodeling. Nonetheless, symptoms, especially dyspnea on exertion and poor exercise tolerance require management of excess fluid volume with dietary sodium restriction in all, and chronic use loop diuretics, in most patients. Fluid removal with intravenous loop diuretics is the most common approach to relieving the worsening symptoms of ADHF. Several devices have an evidence-based role in HFrEF including Cardiac V-Wave.

Resynchronization therapy (CRT), implantable cardioverter/defibrillator (ICD), and left ventricular assist devices (LVAD) for patients with end-stage disease.

HFpEF is different. No randomized trials of medical therapy have achieved their primary endpoint. Other than management of underlying predisposing conditions such as hypertension, and treating symptoms and acute exacerbations with loop diuretics, no effective medical or device therapies have been found for patients with HFpEF with one exception—implantable hemodynamic monitoring, which will be discussed subsequently. These patients often have exercise-induced symptoms.

Irrespective of the state of LV systolic function, most patients tend to have a progressive course characterized by worsening HF stage, symptom class, periodic acute symptomatic worsening with the need for hospitalization, and ultimately death. There remains large unmet medical and societal needs to reduce the incidence of acutely worsening HF in ambulatory patients. The benefits of doing so would likely include reducing HF morbidity and improving the quality-of-life for countless patients while controlling costs and utilization of resources.

Rationale and evidence for interatrial shunting

The V-Wave Shunt is a medical device approach aimed at reducing the incidence of acutely worsening HF in patients with existing severely symptomatic HF. The development of the V-Wave Shunt to treat HF further relies on the following concepts, observations and mitigation of potential risks:

  • The central pathophysiological basis for interatrial shunting is that sustained elevation of left atrial pressure (LAP) directly causes pulmonary congestion with symptoms responsible for 90% of HF hospital admissions.
  • There is an interatrial pressure gradient, that is, LAP exceeds RAP in most patients, most of the
  • It has been observed that heart failure patients with coexisting congenital atrial septal defects may have better outcomes and closure of ASD and PFO may unmask subclinical left ventricular dysfunction by provoking immediate pulmonary
  • Atrial septostomy (creation of an interatrial communication) has been used for decades to improve pressure, or flow for congenital heart disease and for HF.
  • Small interatrial shunts stabilize/reverse progressive LV systolic dysfunction and prevent RV dysfunction in an animal model.
  • The competitive Corvia IASD with Qp:Qs <<1.5 provides evidence of benefit in HFpEF patients and does not result in worsening right heart function or worsening pulmonary hypertension.

If you see patients in your daily practice who have NYHA Class II, III, and IV heart failure, please consider referring them for evaluation for the RELIEVE-HF trial.

Who to contact if you are interested in participating in this study?

For more details about the study please visit the ClinicalTrials.gov website:

Learn more about the Triluminate Trial

Heart failure:

Relieve-HF Trial

  • Treatment for heart failure patients that have not responded to medical therapy

Learn more about the Relieve-HF Trial

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Contact us

Contact us to learn more about these and upcoming clinical trials at Los Robles Health System.

Mane Arabyan – Cardiovascular Research Coordinator
HCA Research Institute at Los Robles Health System
227 West Janss Rd., Suite 340 | Thousand Oaks, CA 91360 | (805) 796-3746
Email Mane

Cherry Papanicolao RN – Cardiovascular Research Coordinator
HCA Research Institute at Los Robles Health System
227 West Janss Rd., Suite 340 | Thousand Oaks, CA 91360 | (805) 368-1803
Email Cherry