Syncardia 50cc Temporary Total Artificial Heart(TAH-t) As A Bridge To Transplant (BTT)

Study on Investigational Device for Biventricular Heart Failure

Recruiting
19 years - 75 years
All
Phase N/A
1 Location

Brief description of study.

The purpose of this study is to see if the investigational device can support people who are at imminent risk of death from biventricular heart failure, eligible for transplant, and for whom the 70cc Total Artificial Heart is not appropriate.

Detailed description of study

The purpose of this study is to see if the investigational device can support people who are at imminent risk of death from biventricular heart failure, eligible for transplant, and for whom the 70cc Total Artificial Heart is not appropriate.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: heart failure,heart,pre-transplant,pretranplant,pre transplant,heart transplant
  • Age: 19 years - 75 years
  • Gender: All

Inclusion Criteria
Risk of imminent death from biventricular heart failure
Two functional atrioventricular (A-V) valves
Adequate room in the chest
Exclusion Criteria
Not cardiac transplant ? eligible
Stroke within 30 days
Dialysis dependent

Updated on 19 Feb 2024. Study ID: 1605941156

The purpose of this study is to investigate if the investigational device can support individuals who are at high risk of death due to biventricular heart failure and are eligible for a heart transplant. Biventricular heart failure is a condition where both sides of the heart are not functioning properly, and this study seeks alternatives for those for whom the 70cc Total Artificial Heart is not suitable.

Participants in the study will undergo procedures involving the investigational device, which aims to provide support for their heart condition. The study will closely monitor participants to assess the effectiveness and safety of the device in managing severe heart failure.

  • Who can participate: Adults who are at risk of imminent death due to biventricular heart failure and have two functional atrioventricular valves may participate. Participants must have adequate room in the chest and be eligible for a heart transplant.
  • Study details: Participants will engage in procedures involving the investigational device to assess its support capabilities. The study will not include any payment for participation.

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