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Ventricular Assist Device

HeartAssist 5® VAD System for Heart Failure

N/A
Waitlist Available
Research Sponsored by ReliantHeart 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 180 days
Awards & highlights

Summary

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.

Eligible Conditions
  • Heart Failure
  • Congestive Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is success at 180 days
Secondary outcome measures
Adverse Events
Functional Status
Neurologic Status
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HeartAssist 5® VAD SystemExperimental Treatment1 Intervention
Implant of the HeartAssist 5® VAD System
Group II: Control VADActive Control1 Intervention

Find a Location

Who is running the clinical trial?

ReliantHeart Inc.Lead Sponsor
~2 spots leftby Sep 2025
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