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Jarvik 2000 VAS for Heart Failure
Study Summary
This trial is testing two different types of devices to see which is better for people with end-stage heart failure. One group will get the Jarvik 2000 LVAS, and the other will get the Thoratec HeartMate II LVAS.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have had a heart transplant or a specific heart surgery to reduce the size of the left ventricle.You are taking medication that weakens your immune system for a long time.Your body surface area is between 1.2 square meters and 2.5 square meters.You have medical conditions, other than heart failure, that may make you unlikely to live for at least three years.Your heart failure is caused by certain medical conditions like thyroid disease, specific heart muscle problems, or inflammation of the heart.You cannot tolerate the medication needed after surgery to prevent blood clots.You are allergic to products made from cows.You are not eligible for a heart transplant.You have had severe heart failure symptoms for most of the past two months.Your heart is not pumping enough blood for your body size.Your heart is not pumping blood well, and it's at 25% capacity or less.You are receiving specific medical treatments for your heart condition or have used certain devices to support your heart within the specified time periods.
- Group 1: HeartMate II Control
- Group 2: Jarvik 2000 Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To whom is this research program available?
"Patients must meet certain criteria to be eligible for this heart failure study. These include age restrictions (18-75) and a diagnosis of myocardial dysfunction. Approximately 350 patients will ultimately take part in the trial."
Are there unfilled vacancies for participants in this experiment?
"Indeed, clinicaltrials.gov shows that this experiment is currently enrolling patients. It was first published on February 1st 2013 and has been recently updated to March 29th 2022 with the aim of recruiting 350 individuals at one site."
Does the eligibility of this trial extend to octogenarians?
"The minimum age requisite for this clinical trial is 18 years old and the upper limit of eligible patients is 75."
What is the cap on recruitment for this clinical exploration?
"Indeed, the information available on clinicaltrials.gov indicates that enrollment for this trial is ongoing. The investigation was originally posted on February 1st 2021 and has since been updated as recently as March 29th 2022; with 350 patients sought from one location."
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