RELIEVE-HF

V-Wave Heart Failure Trial





See If You Qualify

About the RELIEVE-HF
Clinical Trial


RELIEVE-HF is a clinical research study that has been reviewed by the FDA for patients with advanced Heart Failure (HF). The trial is sponsored by V-Wave Ltd. and is designed to test the safety and effectiveness of the investigational V-Wave Interatrial Shunt device. The trial will enroll at up to 75 leading medical centers in the United States, Canada, Europe and Israel.

The RELIEVE-HF clinical research study will include patients with advanced HF and symptom classification known as New York Heart Association (NYHA) Class III and ambulatory class IV. This includes patients who have symptoms such as shortness of breath with minimal or no exertion or difficulty breathing when lying down. Patients may also suffer from fatigue, swollen legs and may have had a hospital admission for HF within the past 12 months or other high-risk features.

For more information, please take a look at our Additional Information section.

Determine if you may be a candidate for RELIEVE-HF

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Additional Information

There are approximately 6 million Americans with HF and more than 800,000 new cases, annually. HF can be the result of many conditions including high blood pressure, coronary disease, certain viral infections and many others. Regardless of cause, patients with HF tend to have high pressure inside their heart especially in the main pumping chamber known as the left ventricle, as well as the left atrium. This situation results in fluid accumulating in the lungs (congestion), leading to shortness of breath. Unfortunately, advanced heart failure patients experience repeated hospitalizations, a poor quality of life, and a greatly reduced life expectancy.
The V-Wave Shunt is an investigational hour-glass shaped device that is advanced through a catheter (a tube) inserted in a vein in the groin and implanted permanently across the wall dividing the right and left atrial chambers of the heart. The procedure is performed in a hospital and typically takes less than ninety minutes. It is expected that patients will remain in a hospital overnight.

The device’s mechanism of action is that as pressure builds up in the left atrium, a small volume of blood is ‘shunted’ to the right atrium through the device relieving the elevated pressure in the left atrium and fluid backup in the lungs. The RELIEVE-HF clinical research study will determine if shunting can improve the function of the heart and reduce symptoms and the need for hospitalization due to worsening heart failure.
The RELIEVE-HF clinical research study will enroll about 500 patients. The first 2-3 patients at each research hospital (about 100 patients) will be treated with the shunt. The remaining 400 patients will be randomly assigned (like a coin toss) to either the shunt or best conventional medical care—about half to each group. Patients and their study physician (a heart failure specialist) will not know their study assignment until the completion of the randomized phase of the study. Should a patient randomized to conventional medical care subsequently wish to be treated with a shunt, they will have that option to do so at the completion of the randomized phase of the trial, assuming they remain eligible for the RELIEVE-HF clinical research study. More information about this study can be found at ClinicalTrials.gov.

See If You Qualify

See If You Qualify


If you are interested in determining if you may be a candidate for the RELIEVE-HF clinical research study, please complete the questionnaire below, as well as the Authorization. TrialTech Medical Inc. is conducting this questionnaire on behalf of V-Wave Ltd.

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 RELIEVE-HF 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 RELIEVE-HF 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 RELIEVE-HF 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 RELIEVE-HF 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 RELIEVE-HF 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 RELIEVE-HF 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 candidates@trialtechmedical.com 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.