A Study Registry of the TandemHeart Blood Pump System to Collect Data to Help Understand Clinical Results

Overview

About this study

This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, it will provide insight into disease defining characteristics that resulted in the clinical decision to use TandemHeart for mechanical support, and also enhance knowledge of best practices regarding clinical management, weaning from the device and removal/exit strategies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria 

  • Has had the TandemHeart System inserted percutaneously (e.g. in the cath lab or peri-operatively)
  • Age > 18 
  • Patient (or legally authorized representative) has signed informed consent

Exclusion Criteria 

  • Is incarcerated (a prisoner) 
  • Is participating in a clinical trial of another investigational device or drug

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

David Joyce, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

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