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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
BSA > 1.2 m2 and < 2.5 m2
Cardiac transplantation ineligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your body surface area is between 1.2 square meters and 2.5 square meters.
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You are not eligible for a heart transplant.
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You have had severe heart failure symptoms for most of the past two months.
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You are receiving specific medical treatments for your heart condition or have used certain devices to support your heart within the specified time periods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-inferiority to Control Group.
Secondary outcome measures
Quality of life measures: Questionnaire
Serious adverse events

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

Find a Location

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

Media Library

Jarvik 2000 VAS (Ventricular Assist Device) Clinical Trial Eligibility Overview. Trial Name: NCT01627821 — N/A
Heart Failure Research Study Groups: HeartMate II Control, Jarvik 2000 Treatment
Heart Failure Clinical Trial 2023: Jarvik 2000 VAS Highlights & Side Effects. Trial Name: NCT01627821 — N/A
Jarvik 2000 VAS (Ventricular Assist Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01627821 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~27 spots leftby Mar 2025