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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
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 moreTrial 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
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Who is running the clinical trial?
ReliantHeart Inc.Lead Sponsor
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