The HeartFlow External Research Program was designed so that investigators, organizations, and industry have an avenue for utilizing HeartFlow technology as part of their study programs in the pursuit of original cardiovascular research and to advance the use of FFRCT to improve human heart health. The ultimate goal of this program is to advance clinical and scientific knowledge of HeartFlow technology and the treatment of cardiovascular disease. This program is open to all academic and community-based physicians and researchers who are interested in conducting their own research.
Typical categories of research that can be submitted for consideration to this program include:
Eligible external research projects are designed, implemented, and sponsored by independent clinical investigators, organizations, or industry sponsors. HeartFlow does not design, conduct, or supervise the research aspects of the proposed study, but may provide limited scientific, technical, data analysis or training assistance related to HeartFlow’s technology.
Any investigator, organization, or industry group requesting research support from HeartFlow will serve as the sponsor of the proposed study and will be expected to perform the responsibilities of ‘sponsor’ as defined by the United States Code of Federal Regulations (21 CFR, Subpart D) and ICH Guidelines for Good Clinical Practices (GCP) concerning Sponsor Responsibilities, as applicable. Sponsor responsibilities include, but are not limited to:
HeartFlow will not formally commit to provide support for any proposed project without a thorough scientific review of study-related materials and without verification that the research has been approved by proper governing bodies (e.g. IRB, EC, and FDA, as applicable). Upon review of the study materials, HeartFlow may provide comments or revisions to the requester regarding the proposed materials.
Proposals are evaluated based upon a variety of factors, including: scientific merit, feasibility to complete the study and publish results, originality of the proposal, and alignment with company focus. During the review, HeartFlow will also evaluate whether an applicant is qualified to receive support based upon the factors that include, but are not limited to: appropriate credentials, education, reputation, demonstrable relevant expertise, research background and training, knowledge of disease or therapeutic area in which the research will be conducted, lack of regulatory authority (e.g., FDA) debarment/disqualification or exclusion and disciplinary action or pending action by any professional licensing body, and ability and potential to successfully conduct the research for which support is requested (including staffing and site resources).
HeartFlow has limited resources and many studies, however the company may support eligible studies by providing HeartFlow products at agreed-upon rates, and by offering limited other research grants, depending on the scope of the project.
Electronic submissions should be made through the link provided at the end of this page.
The average total length of time from submission to communication of the decision regarding support ranges from one to six months, depending on a number of factors. Additional review time may be required as needed.
Upon approval of a research request, HeartFlow requires that the following are in place before initiating formal study support:
Once a proposal is approved, no changes will be allowed to any part of the approved project (i.e. protocol, budget, etc.) absent HeartFlow’s prior written agreement.
HeartFlow requires the sponsor to provide periodic study status updates (including protocol amendments, enrollment progress, study timeline changes, planned publications).