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

NCT02232659 | Unknown DMC

• 1 other identifier: SynCardia 70cc TAH-t for DT
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Probable Benefit

  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).

  Six Months

Secondary Outcomes (1)

• Safety

  Six Months

Study Arms (2)

Primary Arm

EXPERIMENTAL

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

Device: 70cc TAH-t for Destination Therapy

Secondary Arm

EXPERIMENTAL

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

Interventions

70cc TAH-t for Destination Therapy DEVICE

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 Arm; Secondary Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• 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.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ≥ 1.7m2
• Sternum to T10 distance \> 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

You may not qualify if:

• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin \<17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
• Secondary Arm
• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older

Sponsors & Collaborators

• SynCardia Systems. LLC: lead

Study Sites (7)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Banner University Medical Center

Tucson, Arizona, 85726, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Study Officials

• Jack Copeland, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judy Skroback, CIP, CRCP

CONTACT

520-545-1234; jskroback@syncardia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 5, 2014
• Study Start: February 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (7)