Recruiting

SynCardia TAH-t

Sponsor:

SynCardia Systems. LLC

Code:

NCT02232659

Conditions

Life-threatening

Biventricular Heart Failure

Ineligible for Cardiac Transplant

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

70cc TAH-t for Destination Therapy

Study Details

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.

Conditions

Life-threatening

Biventricular Heart Failure

Ineligible for Cardiac Transplant

Study ID

NCT02232659

Start date

Feb, 2016

Status verified date

Mar, 2021

Completion date

May, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Primary Arm

Use of the SynCardia 70cc TAH-t for Destination Therapy to support an HDE Application.

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.

Interventions

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 measure

  • Probable Benefit [ Time Frame: Six Months ]

Central Contacts and Locations

Central contacts

Judy Skroback, CIP, CRCP

520-545-1234jskroback@syncardia.com

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Radha Gopalan, MD

Banner University Medical Center

Recruiting

Tucson, Arizona, United States, 85726

Principal Investigator:

David Bull, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Alfredo Trento, MD

Integris Baptist Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Principal Investigator:

Michael Sasevich, MD

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Igor Gregoric, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

Daniel Tang, MD

Froedtert & the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

David Joyce, MD

More Information

Sponsor

SynCardia Systems. LLC

Last update posted

Mar 17, 2021

Last verified

Mar, 2021

Keywords

  • SynCardia
  • Total Artificial Heart
  • Biventricular heart failure
  • Ineligible for cardiac transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SynCardia Systems. LLC on 2021-03-17.