Total Artificial Heart for Heart Failure

N/A

Recruiting

Research Sponsored by BiVACOR Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biventricular failure with at least two of the following hemodynamic and/or echocardiographic measurements.

Tricuspid insufficiency grade 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months or time of heart transplant (if prior to 6 months post pump implant)

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if the BiVACOR Total Artificial Heart System can help adult patients with severe heart failure who need mechanical circulatory support to stay alive. The study will evaluate the safety and performance

Who is the study for?

This trial is for adults with severe heart failure who need mechanical support to survive and are waiting for a heart transplant. They must have specific heart function measurements like low right ventricular ejection fraction or high central venous pressure, indicating advanced heart issues.

What is being tested?

The study tests the BiVACOR Total Artificial Heart (TAH) System as a temporary solution for patients with severe biventricular or univentricular heart failure until they can get a transplant. It checks if the device is safe and works well in supporting their circulatory system.

What are the potential side effects?

While not explicitly listed, side effects may include complications related to device implantation, such as bleeding, infection, blood clots leading to stroke or other problems, and potential malfunction of the artificial heart system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's two main chambers aren't working well.

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I have severe tricuspid valve leakage.

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My heart condition does not improve with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months or time of heart transplant (if prior to 6 months post pump implant)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months or time of heart transplant (if prior to 6 months post pump implant)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months or time of heart transplant (if prior to 6 months post pump implant) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility Endpoint

Safety Endpoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BiVACOR TAHExperimental Treatment1 Intervention

The BiVACOR TAH System will be implanted as a bridge to transplant (BTT) for adults with severe irreversible biventricular heart failure or univentricular heart failure in which LVAD support is not recommended, and who are eligible for cardiac transplantation.

0 / 3Eligibility criteria met