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Artificial Heart

70cc TAH-t for Destination Therapy for Congestive Heart Failure (RA-540 Trial)

N/A
Waitlist Available
Led By Jack Copeland, MD
Research Sponsored by SynCardia Systems. LLC
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 six months
Awards & highlights

Summary

This trial is to study whether the TAH-t can be used as a life-supporting device for people with failing hearts who are not eligible for transplant.

Eligible Conditions
  • Congestive Heart Failure
  • Emergency
  • Ineligible for Cardiac Transplant

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Probable Benefit
Secondary study objectives
Safety

Trial Design

2Treatment groups
Experimental Treatment
Group I: Secondary ArmExperimental Treatment1 Intervention
Use of the SynCardia 70cc TAH-t for Destination Therapy in a less-restrictive patient population to further characterize the use of the 70cc TAH-t for DT.
Group II: Primary ArmExperimental Treatment1 Intervention
Use of the SynCardia 70cc TAH-t for Destination Therapy to support an HDE Application.

Find a Location

Who is running the clinical trial?

SynCardia Systems. LLCLead Sponsor
4 Previous Clinical Trials
712 Total Patients Enrolled
Jack Copeland, MDPrincipal Investigator
~4 spots leftby Sep 2025
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