MedTrace Logo

Syncardia 50cc TAH-t as a Bridge to Transplant

NCT02459054 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-08-10

No results posted yet for this study

Summary

The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.

The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant:

* The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age.
* The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age.
* The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.

Conditions

  • Heart Failure, Right-Sided
  • Cardiac Failure
  • Heart Failure, Left-Sided

Interventions

DEVICE

SynCardia 50cc temporary Total Artificial Heart (TAH-t)

Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.

Sponsors & Collaborators

  • SynCardia Systems. LLC

    lead INDUSTRY

Principal Investigators

  • David Morales, MD · Children's Hospital Medical Center, Cincinnati

  • Francisco Arabia, MD · Cardiac-Dynamics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-07-29
Completion
2020-07-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459054 on ClinicalTrials.gov