This study is currently not recruiting participants.

SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) POSTMARKET SURVEILLANCE STUDY

Investigation of Patient Outcomes with Total Artificial Heart (TAH-t) Implantation

Not Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This study is being conducted to evaluate whether the patient results achieved when the TAH-t is implanted at hospitals that are trained in the SynCardia Training Program are the same as the patient results that were achieved during the clinical trial.

Detailed description of study

This study is being conducted to evaluate whether the patient results achieved when the TAH-t is implanted at hospitals that are trained in the SynCardia Training Program are the same as the patient results that were achieved during the clinical trial.

Eligibility of study

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

  • Conditions: SYNCARDIA
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the outcomes of patients who receive a Total Artificial Heart (TAH-t) implant at hospitals trained in a specific program. The purpose is to compare these outcomes to those from a previous clinical trial to ensure consistency and reliability.

Participants in the study will undergo the implantation of the TAH-t device. The study will track their health outcomes to see if they match the results from the earlier trial. This involves monitoring various health parameters post-implantation.

  • Who can participate: Individuals eligible for participation typically include adults who require a Total Artificial Heart (TAH-t) due to specific medical conditions. Age criteria and other health factors will determine eligibility.
  • Study details: Participants will receive a Total Artificial Heart (TAH-t) implant, and their health outcomes will be monitored to compare with previous trial results. This section will focus on the actions required from participants during the study.
Updated on 19 Feb 2024. Study ID: 1305011477

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