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Ventricular Assist Device
Jarvik 2000 VAS for Heart Failure
N/A
Recruiting
Research Sponsored by Jarvik Heart, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults with severe heart failure who are not eligible for a heart transplant. They must have been in late-stage heart failure for most of the past two months, have a specific body surface area, and be on optimal medical management or other support like IV inotropes. People can't join if they've had certain cardiac procedures, chronic immunosuppression, conditions limiting survival to under three years, intolerance to blood thinners, or sensitivity to bovine products.
What is being tested?
The study compares two devices designed to help failing hearts: the Jarvik 2000 Left Ventricular Assist System (LVAS) with Post-Auricular Connector and the approved HeartMate II LVAS. It's an open-label trial where participants are randomly assigned one of these treatments as their long-term therapy.
What are the potential side effects?
Potential side effects may include bleeding due to required anti-coagulation therapy post-operation, infection risks from implanted devices, possible device malfunction leading to inadequate heart support or need for replacement surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non-inferiority to Control Group.
Secondary study objectives
Quality of life measures: Questionnaire
Serious adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: HeartMate II ControlActive Control1 Intervention
HeartMate II VAS Control
Group II: Jarvik 2000 TreatmentActive Control1 Intervention
Jarvik 2000 VAS, Post-Auricular Cable
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Who is running the clinical trial?
Jarvik Heart, Inc.Lead Sponsor
2 Previous Clinical Trials
157 Total Patients Enrolled
2 Trials studying Heart Failure
157 Patients Enrolled for Heart Failure
Robert Jarvik, MDStudy ChairJarvik Heart, Inc. SPONSOR
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Heart Failure
150 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: HeartMate II Control
- Group 2: Jarvik 2000 Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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