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Syncardia 50cc TAH-t as a Bridge to Transplant

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ClinicalTrials.gov Identifier: NCT02459054
Recruitment Status : Recruiting
First Posted : June 1, 2015
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure, Right-Sided Cardiac Failure Heart Failure, Left-Sided Device: SynCardia 50cc temporary Total Artificial Heart (TAH-t) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SynCardia 50cc Temporary Total Artificial Heart (TAH-t) as a Bridge to Transplant
Actual Study Start Date : October 2015
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Primary Pediatric Arm
Cardiac transplant-eligible pediatric patients at imminent risk of death from biventricular failure who are 10 - 18 years old at time of TAH-t implant. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
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.

Experimental: Primary Adult Arm
Cardiac transplant-eligible adult patients at imminent risk of death from biventricular failure who are 19 - 75 years old at time of TAH-t implant. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
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.

Experimental: Secondary Arm
Cardiac transplant-eligible pediatric and adult patients at imminent risk of death from biventricular failure who do not meet enrollment criteria for a Primary Arm, but meet less restrictive enrollment criteria for the Secondary Arm. The intervention is implantation with the 50cc temporary Total Artificial Heart as a bridge to transplantation.
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.




Primary Outcome Measures :
  1. Probable Benefit (for Pediatric Arm); Efficacy (for Adult Arm) [ Time Frame: 6 months ]
    Probable benefit will be measured at six months post-implant as either transplanted during the first six months, or continuing on support at six months on the same 50cc TAH-t, without experiencing permanent disabling stroke-related deficits.


Secondary Outcome Measures :
  1. Safety: Performance Goal of Four Adverse Event Categories [ Time Frame: Six months ]
    Safety will be measured by comparison of rate of occurrence of Major infection (sepsis), Neurological event (CVA), Chronic renal dysfunction, and Major device failures/malfunctions against individual performance goals (based on prior 70cc TAH-t experience).



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Primary Pediatric and Adult Arms):

  • At imminent risk of death from biventricular heart failure
  • Aged 10 - 18 years (pediatric); 19 - 75 years (adults) at time of implant
  • With two functional atrioventricular (A-V) valves
  • With Body Surface Area (BSA) of 1.2 through 1.85m2
  • With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

Exclusion Criteria:

  • Patients who are not cardiac transplant-eligible
  • Cardiac transplant-eligible patients

    • Who cannot be adequately anticoagulated on the TAH-t
    • With insufficient space in the chest
    • Who are on extracorporeal membrane oxygenation (ECMO) support > 3 days
  • Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t
  • Patients who have required cardiopulmonary resuscitation (CPR) for > 30 minutes within 14 days prior to proposed implant
  • Patients who have experienced a stroke within 30 days prior to proposed implant
  • Patients who are dialysis-dependent at time of proposed implant

Inclusion Criteria, Secondary Arm (pediatric and adult patients)

  • Not eligible for Primary Arm
  • At imminent risk of death from biventricular heart failure
  • With Body Surface Area (BSA) of 1.2 through 1.85m2
  • With adequate sternum to T10 distance OR Adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

Exclusion Criteria, Secondary Arm:

  • Patients who are not cardiac transplant-eligible
  • Cardiac transplant-eligible patients

    • Who cannot be adequately anticoagulated on the TAH-t
    • With insufficient space in the chest
  • Patients who are being supported by an investigational device at the time of evaluation for a 50cc TAH-t

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459054


Contacts
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Contact: Judy Skroback, CIP, CRCP 520-545-1234 jskroback@syncardia.com

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Sponsors and Collaborators
SynCardia Systems. LLC
Investigators
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Principal Investigator: David Morales, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Francisco Arabia, MD Cardiac-Dynamics

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Responsible Party: SynCardia Systems. LLC
ClinicalTrials.gov Identifier: NCT02459054     History of Changes
Other Study ID Numbers: RA-551
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

Keywords provided by SynCardia Systems. LLC:
Artificial Heart
Biventricular Heart Failure
SynCardia

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases