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SynCardia 70cc TAH-t for Destination Therapy (DT) (RA-540)

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ClinicalTrials.gov Identifier: NCT02232659
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. LLC

Brief Summary:

The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible biventricular heart failure.

The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT).

Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that are experienced by the enrolled subjects and comparing them to previous experience of TAH-t patients who were waiting for a heart transplant. Since approximately 74% of patients with this condition would not be expected to live beyond six months, the benefit of the TAH-t for DT will be confirmed based on survival to six months without experiencing permanent disabling stroke-related deficits. After the six month follow-up visit, patients will continue to be followed under the study for up to five (5) years postTAH-t implant [every six months for up to two years while supported with the TAH-t implant and then annually for another three years].

Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be the same for patients enrolled in both arms of the study.


Condition or disease Intervention/treatment Phase
Life-threatening Biventricular Heart Failure Ineligible for Cardiac Transplant Device: 70cc TAH-t for Destination Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT)
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Arm
Use of the SynCardia 70cc TAH-t for Destination Therapy to support an HDE Application.
Device: 70cc TAH-t for Destination Therapy
Use of the approved SynCardia 70cc TAH-t for patients who are in biventricular failure (approved use), but who are ineligible for cardiac transplant (experimental use).

Experimental: Secondary Arm
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.
Device: 70cc TAH-t for Destination Therapy
Use of the approved SynCardia 70cc TAH-t for patients who are in biventricular failure (approved use), but who are ineligible for cardiac transplant (experimental use).




Primary Outcome Measures :
  1. Probable Benefit [ Time Frame: Six Months ]
    Alive on original TAH-t and free from permanent disabling stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months post-implant (or transplanted prior to six months post-implant).


Secondary Outcome Measures :
  1. Safety [ Time Frame: Six Months ]
    Adverse Events (AEs) will be captured according to the Intermacs Registry AE definitions and will be assessed according to the same data collection schedule followed under the Intermacs Registry protocol for up to two years post-implant. In addition to reporting of rate, number and percent of subjects experiencing each adverse event, individual performance goals have been determined for four adverse event categories, based on the previous experience of patients supported by the TAH-t while awaiting cardiac transplant.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Primary Arm

Inclusion Criteria:

  1. Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
  2. Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
  3. On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
  4. Ambulatory without assistance
  5. Patients between 19 and 75 years of age
  6. Patients with Body Surface Area (BSA) of ≥ 1.7m2
  7. Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

Exclusion Criteria:

  1. Cardiac transplant-eligible patients
  2. Patients who cannot be adequately anticoagulated on the TAH-t
  3. Patients with insufficient space in the chest
  4. Patients on ECMO support
  5. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
  6. Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
  7. Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
  8. Patients with a comorbidity that has a poor prognosis of survival beyond six months
  9. Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)

Secondary Arm

Inclusion Criteria:

  1. Patients who are NOT eligible to participate in the Primary Arm
  2. Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
  3. Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
  4. On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
  5. Patients 19 years of age or older
  6. Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

Exclusion Criteria:

  1. Patients who are less than 19 years old
  2. Cardiac transplant-eligible patients
  3. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
  4. Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
  5. Patients with insufficient space in the chest
  6. Patients who cannot be adequately anticoagulated on the TAH-t
  7. Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)

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): NCT02232659


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

Locations
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United States, Arizona
Banner University Medical Center Recruiting
Tucson, Arizona, United States, 85726
Principal Investigator: David Bull, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Alfredo Trento, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Principal Investigator: Michael Sasevich, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Behzad Soleimani, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Howard Massey, MD         
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Igor Gregoric, MD         
Methodist DeBakey Heart and Vascular Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Brian Bruckner, MD         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Daniel Tang, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Francis Downey, MD         
Froedtert & the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: David Joyce, MD         
Sponsors and Collaborators
SynCardia Systems. LLC
Investigators
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Principal Investigator: Jack Copeland, MD

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Responsible Party: SynCardia Systems. LLC
ClinicalTrials.gov Identifier: NCT02232659     History of Changes
Other Study ID Numbers: SynCardia 70cc TAH-t for DT
First Posted: September 5, 2014    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: April 2018

Keywords provided by SynCardia Systems. LLC:
SynCardia
Total Artificial Heart
Biventricular heart failure
Ineligible for cardiac transplant

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases