An Ongoing Clinical Trial for Advanced Heart Failure

About the PRO-10001 Trial

The NuPulseCV iVAS is an implantable device designed to improve circulation in patients with advanced HF who are not responding well to optimal medical management or guideline-directed therapy. The iVAS blood pump is implanted by insertion through the subclavian artery near the shoulder. Under fluoroscopy, it is advanced into the aorta. The procedure is performed under general anesthesia. Once implanted, the device is connected to a portable drive unit that powers the implanted blood pump. During each cycle of the heartbeat, the device synchronizes with the patient’s heart rhythm such that the blood pump is inflated with air while the heart is relaxing, and then deflated while the heart is contracting. The iVAS is similar to a device called the intra-aortic balloon pump (IABP) that has been around for several decades and is used in patients requiring short-term circulatory support. The iVAS differs principally in that it is connected to a portable pump, allowing greater patient mobility.

IABPs have been shown to provide adequate support in a selected group of acute heart failure patients in cardiogenic shock. Conventionally, IABPs are placed via the femoral artery (near the groin) and are FDA-cleared for short-term use. This approach may be acceptable for acute care; however, due to patient immobilization, it is not well-suited for what doctors call 'bridge to transplantation' (BTT), supporting patients while they are waiting for a transplant. In some cases, the insertion technique has been modified to deliver the IABP via an artery near the shoulder (axillary or subclavian) to allow for improved ambulation and rehabilitation prior to transplant. Using the axillary artery IABP, the University of Chicago Medical Center (UCMC) demonstrated that 90% of BTT patients can receive a heart transplant1. These patients are still required to remain in the hospital. The iVAS device being studied in the PRO-10001 trial uses counterpulsation, a proven and established therapy since the 1960s, which is also the basis for IABPs. The principle behind this therapy is that when the pump inflates it helps increase the blood flow into the arteries of the heart, and when it deflates it lowers the resistance against which the main pumping chamber needs to pump the ejected blood.

iVAS is minimally invasive, non-obligatory (i.e., support can be interrupted at various times without adverse physiologic effect) and allows for complete patient independence, ambulation, and hospital discharge.

The PRO-10001 clinical trial will include up to 100 patients at up to 20 investigational centers. The study is non-randomized, meaning that there will be no placebo group. Eligible patients will be those who suffer from advanced HF despite the best medical therapies and who are in need of circulatory support by a device in order to maintain an acceptable level of cardiac function. Such patients are typically very advanced and many may be candidates for heart transplantation. Patients’ clinical status (transplanted, stroke-free survival, or transplanted for recovery) is evaluated at 30 days per the clinical protocol. However, patients who are unable to be transplanted will have the device left in place until either a donor heart is identified or the physician decides on an alternative course of therapy.

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1Tanaka A, Tuladhar S, Onsager D, et al. The Subclavian Intraaortic Balloon Pump: A Compelling Bridge Device for Advanced Heart Failure. Ann Thorac Surg 2015; Available online 28 July 2015.

Determine if you may be a candidate for the PRO-10001 Advanced Heart Failure Trial

Additional Information

Heart Failure (HF) is a chronic, progressive disease in which the heart muscle is unable to pump enough blood to meet the body’s demands for oxygen and nutrients. HF is a condition that affects people of all ages and ethnicities. This condition may result from any number of diseases or injuries to the heart including prior heart attacks, uncontrolled high blood pressure, viral infections of the heart, pregnancy and many others. HF remains one of the major causes of mortality and chronic illness in the United States and is growing in magnitude. There are 870,000 new cases annually and HF currently affects more than 5 million Americans.

Advanced HF means the condition has progressed and traditional therapies, such as medications and cardiac resynchronization therapy (also known as optimal medical management, or OMM), are no longer optimally working. Advanced HF patients may have symptoms that include frequent trips to the emergency department or hospital, inability to function normally due to severe shortness of breath, fluid in their lungs, low cardiac output, low blood pressure and possibly even damage to other organs such as the kidneys or liver. In many cases, advanced HF patients who no longer are responding to OMM may be candidates for heart transplantation or implantable, mechanical circulatory support (MCS) devices. Unfortunately, there are not enough donor hearts available to supply all patients that might benefit from a heart transplant, and thus doctors may recommend an MCS device, also known as a ventricular assist device (VAD), to help support circulation. There are a number of such devices currently in use and approved by the FDA, but researchers continue to seek alternative and improved solutions.

See If You Qualify

If you are interested in determining if you or a loved one may be a candidate for the PRO-10001 trial, please complete the questionnaire below, as well as the Authorization. TrialTech Medical, Inc., is conducting this questionnaire on behalf of NuPulseCV, Inc.

If you are filling out this form on behalf of a loved one, please respond to the questions from the perspective of the candidate.

1. I understand that I am going to be asked certain questions regarding my personal medical condition by TrialTech Medical, Inc. (“TrialTech”) personnel so they can determine if I might be a suitable candidate for a clinical research study. Initially, I will complete a questionnaire requesting limited information so that an initial evaluation may be made. TrialTech is assisting in the recruitment of suitable candidates for the RePRIEVE-CM clinical research study.

2. Subject to the results of the initial evaluation, I may be referred for a telephone consultation with a TrialTech health care professional who will ask me additional information about my medical condition, general health and medical history. If the health care professional believes that I might be a suitable candidate for the RePRIEVE-CM clinical research study, he or she may use my information to refer me for the purposes of further evaluation to an investigator who is conducting the RELIVE-HF clinical research study at a hospital site or sites nearest to me.

3. I agree to allow TrialTech and its personnel and associates, including the health care professional, to receive the personal information that I am providing and to disclose it to the clinical research study investigator to evaluate my medical condition solely for determining whether I may potentially qualify to participate in the RePRIEVE-CM clinical research study.

4. I understand that it is not guaranteed that I will be determined to be eligible or that I will be accepted to participate in the RePRIEVE-CM clinical research study. Only the clinical investigator can ultimately determine my eligibility.

5. If accepted as a participant in the clinical research study, the clinical investigator will fully inform me about the study, its procedures and risks and will ask me to sign an Informed Consent Form. I understand that my consent contained in this Authorization is not intended to take the place of the Informed Consent Form which I will be asked to sign if I am to become a participant in the RePRIEVE-CM clinical research study.

6. Except as allowed by me pursuant to this Authorization, TrialTech will not use, disclose or sell my personal information or disclose my identity to third parties. Although TrialTech is not a HIPAA covered entity, it has taken reasonable security measures (based on HIPAA requirements) including secure servers, private data services, software encryption and others to protect my personal information disclosed on this site. Notwithstanding, TrialTech disclaims all responsibility for the protection of my personal information by the clinical research study site or other persons or entities who may gain access to my information. There is a possibility that once disclosed to the clinical investigator, privacy laws may no longer protect my information from being given to another person, class of persons, and/or companies.

7. I understand that once information that could be used to identify me has been removed and my information is no longer personally identifiable (i.e. connected to my identity), the anonymized information may be aggregated with anonymized information of others and used for research or business purposes.

8. No publication or presentation of my personal information will reveal my identity without my separate specific written permission and authorization.

9. I understand that I have the right to decline approval of this Authorization. If I refuse, TrialTech will not accept submission of my personal information and I will not be able to be evaluated for the RePRIEVE-CM clinical research study by TrialTech. I understand that subject to review of this questionnaire and my Authorization, I may be contacted by TrialTech personnel to schedule a telephonic interview.

10. I understand that I may change my mind and cancel this Authorization prior to the time that my evaluation by TrialTech is complete. To cancel this Authorization, I must send an email to TrialTech at stating that I wish to cancel. I have been advised to print a copy of this Authorization for my records. This Authorization has no expiration date.