SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT)
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 14
- 主要终点
- Probable Benefit
研究概览
简要总结
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.
详细描述
On 15 October 2004, the SynCardia temporary Total Artificial Heart (TAH-t) received Food and Drug Administration (FDA) approval (Premarket Approval Application [PMA] #P030011) for in-hospital use as a bridge to transplant (BTT) in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
On 2 March 2012, FDA granted a Humanitarian Use Designation (HUD) to the 70cc TAH-t System for use as Destination Therapy (DT) in patients at risk of imminent death from irreversible biventricular heart failure who are not eligible for transplant and have a body surface area (BSA) >1.7m. This clinical study is intended to determine the safety and probable benefit of the 70cc TAH-t for use in DT and support a Humanitarian Device Exemption (HDE) application for this new indication for the TAH-t System.
The SynCardia TAH-t System is a pulsatile biventricular device that replaces a patient's native ventricles and valves by pumping blood to both the pulmonary and systemic circulation.
The TAH-t System for DT consists of the implantable TAH-t with SynHall Valves, powered by PMA-approved external pneumatic drivers [the Circulatory Support System (CSS) Console, the Companion 2 Driver System and the Freedom Driver System]. The TAH-t System is intended to be implanted in the operating room by a qualified surgeon and is capable of supporting the patients both inside and outside the hospital.
The SynCardia TAH-t for DT is indicated for refractory advanced heart failure patients with biventricular failure who are not candidates for cardiac transplant because of the presence of contraindications to transplant, including cancer, advanced age, obesity, end-stage diabetes mellitus, high panel reactive antibodies (PRAs), non-cardiac congenital defects, contraindications to immunosuppression, lack of social support, poor medical compliance, neurological impairment or other co-morbidities with a poor prognosis for survival. Patients with life-threatening, irreversible biventricular failure who are not eligible for transplant currently have no alternative but death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Inclusion Criteria:
- •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
- •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:
- •Patients who are less than 19 years old
- •Cardiac transplant-eligible patients
- •Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
- •Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
- •Patients with insufficient space in the chest
- •Patients who cannot be adequately anticoagulated on the TAH-t
- •Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
结局指标
主要结局
Probable Benefit
时间窗: 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).
次要结局
- Safety(Six Months)